Breast Cancer Female
Conditions
Brief summary
This study is a randomized controlled trial (RCT) to test the efficacy of a Behavioral Activation and Problem Solving (BA/PS) approach to improving activity participation over time as compared to an attention control condition within a sample of 300 breast cancer survivors reporting reduced activity participation after completing cancer treatment.
Detailed description
Assessments will be administered via telephone by a research assistant blind to group assignment. Participants will complete outcome assessments upon enrollment (T1) and at 8 weeks (T2), 20 weeks (T3) and 44 weeks (T4) later. The T2 assessment captures the short-term outcomes of the most intensive part of the intervention (i.e., after six weekly sessions). The T3 assessment will capture the short-term outcomes at the end of the full intervention. The T4 assessment explores the sustained effect of BA/PS (six months after BA/PS ends). The study aim is to test whether the BA/PS intervention affects the slope of functional recovery over time. With the longitudinal data, the investigators will also be able to explore the pace of improvement and whether the two groups differ at these clinically relevant time points.
Interventions
BEHAVIORALThe Behavioral Activation/ Problem Solving Intervention
The interventionist presents the rationale for BA/PS, promotes a positive problem orientation, and educates about the framework for problem-solving and action planning. The interventionist then administers the Canadian Occupational Performance Measure to elicit participant priorities, motivation, and long-term goals. The interventionist then guides the participant in using the BA/PS framework to set a goal, brainstorm solutions to challenges, and create a detailed action plan for the coming week.
BEHAVIORALAttention Control Condition
The interventionist provides education regarding nine cancer survivorship topics (i.e., healthy diets, physical activity, lymphedema management, smoking cessation, stress management, communication with providers, body image and sexuality, communication with social supports, work accommodations) during the control telephone contacts.
Sponsors
National Cancer Institute (NCI)
MGH Institute of Health Professions
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Assessments will be administered via telephone by a research assistant blind to group assignment.
Intervention model description
The investigators will recruit 300 women over the age of 18 reporting participation restrictions after completing curative treatment for Stage 1-3 breast cancer within the past year. Half of the participants will be randomized to the 4-month BA/PS intervention which consists of 6 weekly telephone calls followed by 3 monthly telephone calls. BA/PS is designed to teach problem-solving and action planning to promote functional recovery. The other half of participants will be assigned to an attention control condition providing education about survivorship topics. This control condition will allow us to account for the effect of time and history, and the non-specific effects of attention
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age of 18 years or older. 2. Experiencing reduced participation (i.e., a score greater than or equal to 10 on the Work and Social Adjustment Scale). 3. Females diagnosed with Stage 1-3 breast cancer and within one year of completion of locoregional treatment and/or chemotherapy with curative intent and absence of disease recurrence
Exclusion criteria
1. Non-English speaking. 2. Non-correctable hearing loss. 3. Moderate-severe cognitive impairment indicated by a score \< 3 on a 6-item cognitive screener. 4. History of severe mental illness (i.e., schizophrenia, bipolar disorder), current major depressive disorder, active suicidal ideation, or active substance misuse documented within the medical record.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participation Satisfaction in Social Roles and Activities: PROMIS | The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline) estimated with a linear contrast. | The Patient Reported Outcomes Measurement Information System (PROMIS): Satisfaction with Social Roles and Activities measures satisfaction with daily routines and activities. Raw scores (ranging 8-40) were converted to T-scores (mean = 50, SD = 10) with higher scores indicating better outcomes (i.e., greater satisfaction with daily routines and activities). |
| Work Productivity | The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast. | The Work Limitations Questionnaire-Short Form (WLQ-SF) assesses productivity with an overall score indicating the percentage decrement in productivity in the previous two weeks. Scores range 0-100% with higher scores indicating greater decrement in productivity. |
| Productivity | The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline) estimated with a linear contrast. | Instrument name: Disability Days section of the Medical Expenditure Panel Survey (MEPS). Range: 0- 30 days. Subscales: N/A. Interpretation: Higher values indicate lower productivity. |
| Participation Ability in Social Roles and Activities | The overall treatment effect will be computed as between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast. | The Patient Reported Outcomes Measurement Information System (PROMIS): Ability to Participate in Social Roles and Activities Short Form 8a measures participation with daily routines and activities. Raw scores (ranging 8-40) were converted to T-scores (mean = 50, SD = 10) with higher scores indicating better outcomes (i.e., greater ability to participate in daily routines and activities). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G) | The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast. | The Functional Assessment of Cancer Treatment (FACT) - General measures quality of life. The physical, social, and functional subscale scores can range 0-28 and the emotional subscale score can range 0-24; higher scores indicate better well-being. Overall score was calculated by summing the four subscales; overall scores can range from 0-108 with higher scores indicating better quality of life. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Coping | The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast. | The Brief COPE measures adaptive coping. Range for each subscale (positive reframing, active coping, planning): 2-8; higher values indicate more adaptive coping. Subscales items are summed; no total score. |
| Occupational Performance | The overall treatment effect will be computed as the between-group difference from Session 1 (baseline) and Session 9 (approximately week 20), estimated with a linear contrast. | Instrument name: Canadian Occupational Performance Scale. The participant rates each activity with Likert scales for three characteristics: satisfaction (1- 10), performance (1-10), and importance (1 - 10). Interpretation: Higher values indicate higher occupational performance. |
| Distress | The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast. | Instrument name: Hospital Anxiety and Depression Scale (HADS). Range for each subscale (no total score): 0-21. Subscales: anxiety and depression. Higher values indicate greater anxiety and depression. |
| Goal Adjustment | The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast. | Instrument name: Goal Disengagement and Goal Reengagement Scale (GDGRS). Range: 4 to 20 for goal disengagement and 6 to 30 for goal reengagement. Subscales: goal disengagement and goal reengagement (subscale items are averaged, no total score). Higher values indicate greater tendency to disengage or re-engage with goals. |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred between August 2019 and April 2022. Participants were recruited via Dartmouth College, the University of Alabama at Birmingham (UAB), and via Facebook.
Pre-assignment details
19 participants were enrolled and then excluded from the study before assignment to groups. 2 were excluded due to screen failure and 17 were excluded because they did not complete the baseline assessment.
Participants by arm
| Arm | Count |
|---|---|
| The Behavioral Activation/ Problem Solving Intervention BA/PS teaches survivors to a) systematically examine the reasons an activity is challenging, b) set achievable short-term goals that have the potential to improve participation, c) brainstorm solutions including activity adaptations and environmental modifications, d) construct and implement a detailed action plan, and e) evaluate the results and level of goal attainment. The structured process gives participants repeated practice in goal reengagement that leads them progressively closer to their long-term functional goals. The BA/PS framework integrates the cognitive-behavioral therapies of Behavioral Activation and Problem-solving Treatment and incorporates concepts from an occupational therapy theory called the Person-Environment-Occupational Performance Model.
The Behavioral Activation/ Problem Solving Intervention: The interventionist presents the rationale for BA/PS, promotes a positive problem orientation, and educates about the framework for problem-solving and action planning. The interventionist then administers the Canadian Occupational Performance Measure to elicit participant priorities, motivation, and long-term goals. The interventionist then guides the participant in using the BA/PS framework to set a goal, brainstorm solutions to challenges, and create a detailed action plan for the coming week. | 144 |
| Attention Control Condition Investigators provide education regarding nine cancer survivorship topics (i.e., healthy diets, physical activity, lymphedema management, smoking cessation, stress management, communication with providers, body image and sexuality, communication with social supports, work accommodations) during the control telephone contacts. The control condition will match the intervention in terms of the number of sessions, the delivery by telephone, use of an occupational therapist, and the use of homework between sessions (i.e., reading the education materials for the control condition versus executing the action plan for the BA/PS condition).
Attention Control Condition: The interventionist provides education regarding nine cancer survivorship topics (i.e., healthy diets, physical activity, lymphedema management, smoking cessation, stress management, communication with providers, body image and sexuality, communication with social supports, work accommodations) during the control telephone contacts. | 140 |
| Total | 284 |
Baseline characteristics
| Characteristic | Attention Control Condition | Total | The Behavioral Activation/ Problem Solving Intervention |
|---|---|---|---|
| Age, Continuous | 56.2 Years STANDARD_DEVIATION 10.6 | 56.1 Years STANDARD_DEVIATION 10.2 | 56 Years STANDARD_DEVIATION 9.9 |
| Brief COPE Active coping | 6.5 units on a scale STANDARD_DEVIATION 1.6 | 6.4 units on a scale STANDARD_DEVIATION 1.6 | 6.3 units on a scale STANDARD_DEVIATION 1.5 |
| Brief COPE Planning | 6.6 units on a scale STANDARD_DEVIATION 1.6 | 6.4 units on a scale STANDARD_DEVIATION 1.7 | 6.3 units on a scale STANDARD_DEVIATION 1.7 |
| Brief COPE Positive reframing | 6.6 units on a scale STANDARD_DEVIATION 1.7 | 6.4 units on a scale STANDARD_DEVIATION 1.7 | 6.4 units on a scale STANDARD_DEVIATION 1.7 |
| Cancer Stage Stage I | 64 Participants | 119 Participants | 55 Participants |
| Cancer Stage Stage II | 53 Participants | 113 Participants | 60 Participants |
| Cancer Stage Stage III | 23 Participants | 52 Participants | 29 Participants |
| Cancer Treatment Chemotherapy | 90 Participants | 186 Participants | 96 Participants |
| Cancer Treatment Radiation | 100 Participants | 218 Participants | 118 Participants |
| Cancer Treatment Surgery | 139 Participants | 282 Participants | 143 Participants |
| Disability Days Days in Bed | 4.2 Days STANDARD_DEVIATION 7.3 | 3.5 Days STANDARD_DEVIATION 6.4 | 2.8 Days STANDARD_DEVIATION 5.3 |
| Disability Days Days Miss Work | 2.1 Days STANDARD_DEVIATION 4.5 | 2.5 Days STANDARD_DEVIATION 5.3 | 3 Days STANDARD_DEVIATION 6 |
| Education Level Graduate (4 year, Master's, Doctoral) | 92 Participants | 190 Participants | 98 Participants |
| Education Level Missing | 0 Participants | 2 Participants | 2 Participants |
| Education Level Some College (2 year) | 30 Participants | 65 Participants | 35 Participants |
| Education Level Some High school/High school Graduate | 18 Participants | 27 Participants | 9 Participants |
| Employment Status Employed (FT/PT) | 77 Participants | 152 Participants | 75 Participants |
| Employment Status Homemaker/Retired | 35 Participants | 77 Participants | 42 Participants |
| Employment Status Missing | 0 Participants | 2 Participants | 2 Participants |
| Employment Status On Short/Long Term Disability | 13 Participants | 25 Participants | 12 Participants |
| Employment Status Other | 3 Participants | 6 Participants | 3 Participants |
| Employment Status Unemployed | 12 Participants | 22 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 6 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 138 Participants | 278 Participants | 140 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Goal Adjustment Scale Disengagement | 10.9 units on a scale STANDARD_DEVIATION 3.3 | 10.4 units on a scale STANDARD_DEVIATION 3.1 | 10 units on a scale STANDARD_DEVIATION 2.9 |
| Goal Adjustment Scale Reengagement | 21.2 units on a scale STANDARD_DEVIATION 3.9 | 21.3 units on a scale STANDARD_DEVIATION 3.9 | 21.5 units on a scale STANDARD_DEVIATION 3.8 |
| Hospital Anxiety Depression Scale (HADS) Anxiety | 9.0 units on a scale STANDARD_DEVIATION 4.3 | 9.2 units on a scale STANDARD_DEVIATION 4.3 | 9.4 units on a scale STANDARD_DEVIATION 4.3 |
| Hospital Anxiety Depression Scale (HADS) Depression | 6.7 units on a scale STANDARD_DEVIATION 4.1 | 6.3 units on a scale STANDARD_DEVIATION 3.8 | 6.0 units on a scale STANDARD_DEVIATION 3.5 |
| Household Income $40,000 per year or more | 106 Participants | 220 Participants | 114 Participants |
| Household Income Less than $40,000 per year | 32 Participants | 60 Participants | 28 Participants |
| Household Income Missing | 2 Participants | 4 Participants | 2 Participants |
| Insurance Status Medicaid/Medicare, or other government insurance | 41 Participants | 78 Participants | 37 Participants |
| Insurance Status Missing | 6 Participants | 13 Participants | 7 Participants |
| Insurance Status Other/None, Self pay | 8 Participants | 12 Participants | 4 Participants |
| Insurance Status Private through employer | 85 Participants | 181 Participants | 96 Participants |
| Marital Status Married/Living with a partner | 89 Participants | 187 Participants | 98 Participants |
| Marital Status Missing | 0 Participants | 1 Participants | 1 Participants |
| Marital Status Never Married | 11 Participants | 19 Participants | 8 Participants |
| Marital Status Separated/Divorced | 33 Participants | 65 Participants | 32 Participants |
| Marital Status Widowed | 7 Participants | 12 Participants | 5 Participants |
| Number of Dependent Children Living at Home 0 | 95 Participants | 198 Participants | 103 Participants |
| Number of Dependent Children Living at Home 1 | 21 Participants | 42 Participants | 21 Participants |
| Number of Dependent Children Living at Home 2 | 16 Participants | 31 Participants | 15 Participants |
| Number of Dependent Children Living at Home 3 | 6 Participants | 9 Participants | 3 Participants |
| Number of Dependent Children Living at Home 4 | 2 Participants | 3 Participants | 1 Participants |
| Number of Dependent Children Living at Home Missing | 0 Participants | 1 Participants | 1 Participants |
| PROMIS: Ability to Participate in Social Roles & Activities | 43.3 T-score STANDARD_DEVIATION 5.5 | 43.3 T-score STANDARD_DEVIATION 5.3 | 43.4 T-score STANDARD_DEVIATION 5.2 |
| PROMIS: Satisfaction with Social Roles & Activities | 45.8 T-score STANDARD_DEVIATION 6.9 | 45.7 T-score STANDARD_DEVIATION 6.7 | 45.6 T-score STANDARD_DEVIATION 6.5 |
| Quality of Life, FACT-G Emotional | 15.8 units on a scale STANDARD_DEVIATION 4.6 | 15.9 units on a scale STANDARD_DEVIATION 4.6 | 15.9 units on a scale STANDARD_DEVIATION 4.5 |
| Quality of Life, FACT-G Functional | 16.2 units on a scale STANDARD_DEVIATION 5.3 | 16.4 units on a scale STANDARD_DEVIATION 5.3 | 16.5 units on a scale STANDARD_DEVIATION 5.3 |
| Quality of Life, FACT-G Overall Score | 68.1 units on a scale STANDARD_DEVIATION 17.5 | 68.7 units on a scale STANDARD_DEVIATION 16.9 | 69.3 units on a scale STANDARD_DEVIATION 16.3 |
| Quality of Life, FACT-G Physical | 17 units on a scale STANDARD_DEVIATION 5.2 | 17.0 units on a scale STANDARD_DEVIATION 5.3 | 17 units on a scale STANDARD_DEVIATION 5.5 |
| Quality of Life, FACT-G Social | 19.1 units on a scale STANDARD_DEVIATION 6.5 | 19.5 units on a scale STANDARD_DEVIATION 5.9 | 19.9 units on a scale STANDARD_DEVIATION 5.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 29 Participants | 47 Participants | 18 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 110 Participants | 234 Participants | 124 Participants |
| Region of Enrollment United States | 140 Participants | 284 Participants | 144 Participants |
| Rurality Missing | 5 Participants | 10 Participants | 5 Participants |
| Rurality Rural | 49 Participants | 93 Participants | 44 Participants |
| Rurality Urban | 86 Participants | 181 Participants | 95 Participants |
| Sex: Female, Male Female | 140 Participants | 284 Participants | 144 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Time Since End of Primary Cancer Treatment <6 months | 81 Participants | 163 Participants | 82 Participants |
| Time Since End of Primary Cancer Treatment >6 months | 59 Participants | 121 Participants | 62 Participants |
| Work and Social Adjustment Scale (WASA) score | 17.5 units on a scale STANDARD_DEVIATION 7.1 | 16.9 units on a scale STANDARD_DEVIATION 6.8 | 16.3 units on a scale STANDARD_DEVIATION 6.5 |
| Work Limitations Questionnaire scale score | 36.0 units on a scale STANDARD_DEVIATION 19.3 | 35.3 units on a scale STANDARD_DEVIATION 18.3 | 34.5 units on a scale STANDARD_DEVIATION 17.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 144 | 0 / 140 |
| other Total, other adverse events | 0 / 144 | 0 / 140 |
| serious Total, serious adverse events | 0 / 144 | 0 / 140 |
Outcome results
Primary
Participation Ability in Social Roles and Activities
The Patient Reported Outcomes Measurement Information System (PROMIS): Ability to Participate in Social Roles and Activities Short Form 8a measures participation with daily routines and activities. Raw scores (ranging 8-40) were converted to T-scores (mean = 50, SD = 10) with higher scores indicating better outcomes (i.e., greater ability to participate in daily routines and activities).
Time frame: The overall treatment effect will be computed as between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast.
Population: All available data were used for the linear contrasts. See Participant Flow for reasons for missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| The Behavioral Activation/ Problem Solving Intervention | Participation Ability in Social Roles and Activities | Week 0 | 43.55 T-scores | Standard Error 0.4 |
| The Behavioral Activation/ Problem Solving Intervention | Participation Ability in Social Roles and Activities | Week 8 | 45.55 T-scores | Standard Error 0.43 |
| The Behavioral Activation/ Problem Solving Intervention | Participation Ability in Social Roles and Activities | Week 20 | 47.27 T-scores | Standard Error 0.43 |
| The Behavioral Activation/ Problem Solving Intervention | Participation Ability in Social Roles and Activities | Week 44 | 47.43 T-scores | Standard Error 0.44 |
| Attention Control Condition | Participation Ability in Social Roles and Activities | Week 44 | 48.63 T-scores | Standard Error 0.45 |
| Attention Control Condition | Participation Ability in Social Roles and Activities | Week 0 | 43.48 T-scores | Standard Error 0.41 |
| Attention Control Condition | Participation Ability in Social Roles and Activities | Week 20 | 46.44 T-scores | Standard Error 0.43 |
| Attention Control Condition | Participation Ability in Social Roles and Activities | Week 8 | 44.95 T-scores | Standard Error 0.43 |
p-value: 0.09Mixed Models Analysis
Primary
Participation Satisfaction in Social Roles and Activities: PROMIS
The Patient Reported Outcomes Measurement Information System (PROMIS): Satisfaction with Social Roles and Activities measures satisfaction with daily routines and activities. Raw scores (ranging 8-40) were converted to T-scores (mean = 50, SD = 10) with higher scores indicating better outcomes (i.e., greater satisfaction with daily routines and activities).
Time frame: The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline) estimated with a linear contrast.
Population: All available data were used for the linear contrasts. See Participant Flow for reasons for missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| The Behavioral Activation/ Problem Solving Intervention | Participation Satisfaction in Social Roles and Activities: PROMIS | Week 0 | 45.75 T-score | Standard Error 0.43 |
| The Behavioral Activation/ Problem Solving Intervention | Participation Satisfaction in Social Roles and Activities: PROMIS | Week 8 | 48.09 T-score | Standard Error 0.47 |
| The Behavioral Activation/ Problem Solving Intervention | Participation Satisfaction in Social Roles and Activities: PROMIS | Week 20 | 50.47 T-score | Standard Error 0.47 |
| The Behavioral Activation/ Problem Solving Intervention | Participation Satisfaction in Social Roles and Activities: PROMIS | Week 44 | 50.85 T-score | Standard Error 0.48 |
| Attention Control Condition | Participation Satisfaction in Social Roles and Activities: PROMIS | Week 44 | 51.39 T-score | Standard Error 0.49 |
| Attention Control Condition | Participation Satisfaction in Social Roles and Activities: PROMIS | Week 0 | 46 T-score | Standard Error 0.44 |
| Attention Control Condition | Participation Satisfaction in Social Roles and Activities: PROMIS | Week 20 | 49.81 T-score | Standard Error 0.47 |
| Attention Control Condition | Participation Satisfaction in Social Roles and Activities: PROMIS | Week 8 | 47.61 T-score | Standard Error 0.46 |
p-value: 0.54Mixed Models Analysis
Primary
Productivity
Instrument name: Disability Days section of the Medical Expenditure Panel Survey (MEPS). Range: 0- 30 days. Subscales: N/A. Interpretation: Higher values indicate lower productivity.
Time frame: The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline) estimated with a linear contrast.
Population: All available data were used for the linear contrasts. See Participant Flow for reasons for missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| The Behavioral Activation/ Problem Solving Intervention | Productivity | Week 0 | 1.32 days | Standard Error 0.17 |
| The Behavioral Activation/ Problem Solving Intervention | Productivity | Week 8 | 1.03 days | Standard Error 0.14 |
| The Behavioral Activation/ Problem Solving Intervention | Productivity | Week 20 | 1.22 days | Standard Error 0.16 |
| The Behavioral Activation/ Problem Solving Intervention | Productivity | Week 44 | .88 days | Standard Error 0.13 |
| Attention Control Condition | Productivity | Week 44 | .76 days | Standard Error 0.11 |
| Attention Control Condition | Productivity | Week 0 | 1.15 days | Standard Error 0.15 |
| Attention Control Condition | Productivity | Week 20 | .87 days | Standard Error 0.12 |
| Attention Control Condition | Productivity | Week 8 | .91 days | Standard Error 0.12 |
p-value: 0.55Mixed Models Analysis
Primary
Work Productivity
The Work Limitations Questionnaire-Short Form (WLQ-SF) assesses productivity with an overall score indicating the percentage decrement in productivity in the previous two weeks. Scores range 0-100% with higher scores indicating greater decrement in productivity.
Time frame: The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast.
Population: All available data were used for the linear contrasts. See Participant Flow for reasons for missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| The Behavioral Activation/ Problem Solving Intervention | Work Productivity | Week 0 | 34.7 score on a scale | Standard Error 1.58 |
| The Behavioral Activation/ Problem Solving Intervention | Work Productivity | Week 8 | 27.87 score on a scale | Standard Error 1.71 |
| The Behavioral Activation/ Problem Solving Intervention | Work Productivity | Week 20 | 25.13 score on a scale | Standard Error 1.73 |
| The Behavioral Activation/ Problem Solving Intervention | Work Productivity | Week 44 | 22.79 score on a scale | Standard Error 1.73 |
| Attention Control Condition | Work Productivity | Week 44 | 21.14 score on a scale | Standard Error 1.75 |
| Attention Control Condition | Work Productivity | Week 0 | 34.15 score on a scale | Standard Error 1.6 |
| Attention Control Condition | Work Productivity | Week 20 | 23.57 score on a scale | Standard Error 1.69 |
| Attention Control Condition | Work Productivity | Week 8 | 25.35 score on a scale | Standard Error 1.67 |
p-value: 0.99Mixed Models Analysis
Secondary
Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G)
The Functional Assessment of Cancer Treatment (FACT) - General measures quality of life. The physical, social, and functional subscale scores can range 0-28 and the emotional subscale score can range 0-24; higher scores indicate better well-being. Overall score was calculated by summing the four subscales; overall scores can range from 0-108 with higher scores indicating better quality of life.
Time frame: The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast.
Population: All available data were used for the linear contrasts. See Participant Flow for reasons for missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| The Behavioral Activation/ Problem Solving Intervention | Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G) | Overall score: Week 0 | 69.66 score on a scale | Standard Error 0.87 |
| The Behavioral Activation/ Problem Solving Intervention | Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G) | Overall score: Week 8 | 73.44 score on a scale | Standard Error 0.93 |
| The Behavioral Activation/ Problem Solving Intervention | Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G) | Overall score: Week 20 | 76.25 score on a scale | Standard Error 0.93 |
| The Behavioral Activation/ Problem Solving Intervention | Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G) | Overall score: Week 44 | 76.16 score on a scale | Standard Error 0.95 |
| The Behavioral Activation/ Problem Solving Intervention | Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G) | Physical subscale: Week 0 | 17.21 score on a scale | Standard Error 0.31 |
| The Behavioral Activation/ Problem Solving Intervention | Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G) | Physical subscale: Week 8 | 18.96 score on a scale | Standard Error 0.33 |
| The Behavioral Activation/ Problem Solving Intervention | Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G) | Physical subscale: Week 20 | 19.78 score on a scale | Standard Error 0.33 |
| The Behavioral Activation/ Problem Solving Intervention | Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G) | Physical subscale: Week 44 | 19.59 score on a scale | Standard Error 0.34 |
| The Behavioral Activation/ Problem Solving Intervention | Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G) | Social subscale: Week 0 | 19.79 score on a scale | Standard Error 0.31 |
| The Behavioral Activation/ Problem Solving Intervention | Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G) | Social subscale: Week 8 | 19.39 score on a scale | Standard Error 0.33 |
| The Behavioral Activation/ Problem Solving Intervention | Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G) | Social subscale: Week 20 | 20.14 score on a scale | Standard Error 0.34 |
| The Behavioral Activation/ Problem Solving Intervention | Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G) | Social subscale: Week 44 | 19.76 score on a scale | Standard Error 0.34 |
| The Behavioral Activation/ Problem Solving Intervention | Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G) | Emotional subscale: Week 0 | 15.99 score on a scale | Standard Error 0.24 |
| The Behavioral Activation/ Problem Solving Intervention | Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G) | Emotional subscale: Week 8 | 17.2 score on a scale | Standard Error 0.25 |
| The Behavioral Activation/ Problem Solving Intervention | Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G) | Emotional subscale: Week 20 | 17.66 score on a scale | Standard Error 0.26 |
| The Behavioral Activation/ Problem Solving Intervention | Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G) | Emotional subscale: Week 44 | 17.6 score on a scale | Standard Error 0.26 |
| The Behavioral Activation/ Problem Solving Intervention | Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G) | Functional subscale: Week 0 | 16.56 score on a scale | Standard Error 0.31 |
| The Behavioral Activation/ Problem Solving Intervention | Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G) | Functional subscale: Week 8 | 17.78 score on a scale | Standard Error 0.33 |
| The Behavioral Activation/ Problem Solving Intervention | Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G) | Functional subscale: Week 20 | 18.58 score on a scale | Standard Error 0.33 |
| The Behavioral Activation/ Problem Solving Intervention | Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G) | Functional subscale: Week 44 | 19.11 score on a scale | Standard Error 0.33 |
| Attention Control Condition | Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G) | Functional subscale: Week 8 | 18.17 score on a scale | Standard Error 0.33 |
| Attention Control Condition | Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G) | Overall score: Week 0 | 69.45 score on a scale | Standard Error 0.89 |
| Attention Control Condition | Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G) | Social subscale: Week 20 | 20.07 score on a scale | Standard Error 0.34 |
| Attention Control Condition | Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G) | Overall score: Week 8 | 73.36 score on a scale | Standard Error 0.92 |
| Attention Control Condition | Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G) | Emotional subscale: Week 44 | 17.55 score on a scale | Standard Error 0.26 |
| Attention Control Condition | Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G) | Overall score: Week 20 | 76.49 score on a scale | Standard Error 0.93 |
| Attention Control Condition | Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G) | Social subscale: Week 44 | 19.97 score on a scale | Standard Error 0.35 |
| Attention Control Condition | Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G) | Overall score: Week 44 | 76.23 score on a scale | Standard Error 0.97 |
| Attention Control Condition | Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G) | Functional subscale: Week 44 | 19.28 score on a scale | Standard Error 0.34 |
| Attention Control Condition | Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G) | Physical subscale: Week 0 | 17.31 score on a scale | Standard Error 0.32 |
| Attention Control Condition | Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G) | Emotional subscale: Week 0 | 16.01 score on a scale | Standard Error 0.24 |
| Attention Control Condition | Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G) | Physical subscale: Week 8 | 18.82 score on a scale | Standard Error 0.33 |
| Attention Control Condition | Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G) | Functional subscale: Week 0 | 16.59 score on a scale | Standard Error 0.31 |
| Attention Control Condition | Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G) | Physical subscale: Week 20 | 20.01 score on a scale | Standard Error 0.33 |
| Attention Control Condition | Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G) | Emotional subscale: Week 8 | 16.75 score on a scale | Standard Error 0.25 |
| Attention Control Condition | Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G) | Physical subscale: Week 44 | 19.55 score on a scale | Standard Error 0.35 |
| Attention Control Condition | Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G) | Functional subscale: Week 20 | 19.01 score on a scale | Standard Error 0.33 |
| Attention Control Condition | Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G) | Social subscale: Week 0 | 19.64 score on a scale | Standard Error 0.32 |
| Attention Control Condition | Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G) | Emotional subscale: Week 20 | 17.48 score on a scale | Standard Error 0.25 |
| Attention Control Condition | Quality of Life: Functional Assessment of Cancer Therapy- (FACT-G) | Social subscale: Week 8 | 19.69 score on a scale | Standard Error 0.33 |
p-value: 0.99Mixed Models Analysis
Other Pre-specified
Coping
The Brief COPE measures adaptive coping. Range for each subscale (positive reframing, active coping, planning): 2-8; higher values indicate more adaptive coping. Subscales items are summed; no total score.
Time frame: The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast.
Population: All available data were used for the linear contrasts. See Participant Flow for reasons for missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| The Behavioral Activation/ Problem Solving Intervention | Coping | Active coping: Week 0 | 6.35 score on a scale | Standard Error 0.11 |
| The Behavioral Activation/ Problem Solving Intervention | Coping | Active coping: Week 8 | 6.68 score on a scale | Standard Error 0.11 |
| The Behavioral Activation/ Problem Solving Intervention | Coping | Active coping: Week 20 | 6.68 score on a scale | Standard Error 0.12 |
| The Behavioral Activation/ Problem Solving Intervention | Coping | Active coping: Week 44 | 6.55 score on a scale | Standard Error 0.12 |
| The Behavioral Activation/ Problem Solving Intervention | Coping | Planning: Week 0 | 6.33 score on a scale | Standard Error 0.12 |
| The Behavioral Activation/ Problem Solving Intervention | Coping | Planning: Week 8 | 6.8 score on a scale | Standard Error 0.13 |
| The Behavioral Activation/ Problem Solving Intervention | Coping | Planning: Week 20 | 6.95 score on a scale | Standard Error 0.13 |
| The Behavioral Activation/ Problem Solving Intervention | Coping | Planning: Week 44 | 6.52 score on a scale | Standard Error 0.13 |
| The Behavioral Activation/ Problem Solving Intervention | Coping | Positive reframing: Week 0 | 6.35 score on a scale | Standard Error 0.11 |
| The Behavioral Activation/ Problem Solving Intervention | Coping | Positive reframing: Week 8 | 6.6 score on a scale | Standard Error 0.12 |
| The Behavioral Activation/ Problem Solving Intervention | Coping | Positive reframing: Week 20 | 6.58 score on a scale | Standard Error 0.12 |
| The Behavioral Activation/ Problem Solving Intervention | Coping | Positive reframing: Week 44 | 6.4 score on a scale | Standard Error 0.12 |
| Attention Control Condition | Coping | Positive reframing: Week 20 | 6.56 score on a scale | Standard Error 0.12 |
| Attention Control Condition | Coping | Active coping: Week 0 | 6.48 score on a scale | Standard Error 0.11 |
| Attention Control Condition | Coping | Planning: Week 20 | 6.53 score on a scale | Standard Error 0.13 |
| Attention Control Condition | Coping | Active coping: Week 8 | 6.58 score on a scale | Standard Error 0.11 |
| Attention Control Condition | Coping | Positive reframing: Week 8 | 6.57 score on a scale | Standard Error 0.12 |
| Attention Control Condition | Coping | Active coping: Week 20 | 6.58 score on a scale | Standard Error 0.12 |
| Attention Control Condition | Coping | Planning: Week 44 | 6.5 score on a scale | Standard Error 0.13 |
| Attention Control Condition | Coping | Active coping: Week 44 | 6.35 score on a scale | Standard Error 0.12 |
| Attention Control Condition | Coping | Positive reframing: Week 44 | 6.48 score on a scale | Standard Error 0.12 |
| Attention Control Condition | Coping | Planning: Week 0 | 6.54 score on a scale | Standard Error 0.12 |
| Attention Control Condition | Coping | Positive reframing: Week 0 | 6.48 score on a scale | Standard Error 0.11 |
| Attention Control Condition | Coping | Planning: Week 8 | 6.58 score on a scale | Standard Error 0.12 |
p-value: 0.99Mixed Models Analysis
Other Pre-specified
Distress
Instrument name: Hospital Anxiety and Depression Scale (HADS). Range for each subscale (no total score): 0-21. Subscales: anxiety and depression. Higher values indicate greater anxiety and depression.
Time frame: The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast.
Population: All available data were used for the linear contrasts. See Participant Flow for reasons for missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| The Behavioral Activation/ Problem Solving Intervention | Distress | Anxiety: Week 0 | 9.08 score on a scale | Standard Error 0.22 |
| The Behavioral Activation/ Problem Solving Intervention | Distress | Anxiety: Week 8 | 7.79 score on a scale | Standard Error 0.24 |
| The Behavioral Activation/ Problem Solving Intervention | Distress | Anxiety: Week 20 | 7.44 score on a scale | Standard Error 0.24 |
| The Behavioral Activation/ Problem Solving Intervention | Distress | Anxiety: Week 44 | 7.42 score on a scale | Standard Error 0.24 |
| The Behavioral Activation/ Problem Solving Intervention | Distress | Depression: Week 0 | 6.13 score on a scale | Standard Error 0.21 |
| The Behavioral Activation/ Problem Solving Intervention | Distress | Depression: Week 8 | 5.17 score on a scale | Standard Error 0.22 |
| The Behavioral Activation/ Problem Solving Intervention | Distress | Depression: Week 20 | 4.87 score on a scale | Standard Error 0.22 |
| The Behavioral Activation/ Problem Solving Intervention | Distress | Depression: Week 44 | 5.2 score on a scale | Standard Error 0.23 |
| Attention Control Condition | Distress | Depression: Week 44 | 4.89 score on a scale | Standard Error 0.23 |
| Attention Control Condition | Distress | Anxiety: Week 0 | 8.98 score on a scale | Standard Error 0.23 |
| Attention Control Condition | Distress | Depression: Week 0 | 6.28 score on a scale | Standard Error 0.21 |
| Attention Control Condition | Distress | Anxiety: Week 8 | 7.68 score on a scale | Standard Error 0.24 |
| Attention Control Condition | Distress | Depression: Week 20 | 5.18 score on a scale | Standard Error 0.22 |
| Attention Control Condition | Distress | Anxiety: Week 20 | 7.49 score on a scale | Standard Error 0.24 |
| Attention Control Condition | Distress | Depression: Week 8 | 5.33 score on a scale | Standard Error 0.22 |
| Attention Control Condition | Distress | Anxiety: Week 44 | 7.19 score on a scale | Standard Error 0.25 |
p-value: 0.99Mixed Models Analysis
Other Pre-specified
Goal Adjustment
Instrument name: Goal Disengagement and Goal Reengagement Scale (GDGRS). Range: 4 to 20 for goal disengagement and 6 to 30 for goal reengagement. Subscales: goal disengagement and goal reengagement (subscale items are averaged, no total score). Higher values indicate greater tendency to disengage or re-engage with goals.
Time frame: The overall treatment effect will be computed as the between-group differences at weeks 8, 20, 44 (adjusted for baseline), estimated with a linear contrast.
Population: All available data were used for the linear contrasts. See Participant Flow for reasons for missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| The Behavioral Activation/ Problem Solving Intervention | Goal Adjustment | Disengagement: Week 0 | 10.3 score on a scale | Standard Error 0.21 |
| The Behavioral Activation/ Problem Solving Intervention | Goal Adjustment | Disengagement: Week 8 | 11.3 score on a scale | Standard Error 0.23 |
| The Behavioral Activation/ Problem Solving Intervention | Goal Adjustment | Disengagement: Week 20 | 11.29 score on a scale | Standard Error 0.23 |
| The Behavioral Activation/ Problem Solving Intervention | Goal Adjustment | Disengagement: Week 44 | 11.47 score on a scale | Standard Error 0.23 |
| The Behavioral Activation/ Problem Solving Intervention | Goal Adjustment | Reengagement: Week 0 | 21.26 score on a scale | Standard Error 0.27 |
| The Behavioral Activation/ Problem Solving Intervention | Goal Adjustment | Reengagement: Week 8 | 21.4 score on a scale | Standard Error 0.29 |
| The Behavioral Activation/ Problem Solving Intervention | Goal Adjustment | Reengagement: Week 20 | 22.03 score on a scale | Standard Error 0.3 |
| The Behavioral Activation/ Problem Solving Intervention | Goal Adjustment | Reengagement: Week 44 | 21.5 score on a scale | Standard Error 0.3 |
| Attention Control Condition | Goal Adjustment | Reengagement: Week 44 | 22.03 score on a scale | Standard Error 0.31 |
| Attention Control Condition | Goal Adjustment | Disengagement: Week 0 | 10.6 score on a scale | Standard Error 0.22 |
| Attention Control Condition | Goal Adjustment | Reengagement: Week 0 | 21.14 score on a scale | Standard Error 0.28 |
| Attention Control Condition | Goal Adjustment | Disengagement: Week 8 | 10.67 score on a scale | Standard Error 0.22 |
| Attention Control Condition | Goal Adjustment | Reengagement: Week 20 | 22.01 score on a scale | Standard Error 0.29 |
| Attention Control Condition | Goal Adjustment | Disengagement: Week 20 | 10.43 score on a scale | Standard Error 0.23 |
| Attention Control Condition | Goal Adjustment | Reengagement: Week 8 | 21.81 score on a scale | Standard Error 0.29 |
| Attention Control Condition | Goal Adjustment | Disengagement: Week 44 | 10.39 score on a scale | Standard Error 0.24 |
p-value: 0.02Mixed Models Analysis
Other Pre-specified
Occupational Performance
Instrument name: Canadian Occupational Performance Scale. The participant rates each activity with Likert scales for three characteristics: satisfaction (1- 10), performance (1-10), and importance (1 - 10). Interpretation: Higher values indicate higher occupational performance.
Time frame: The overall treatment effect will be computed as the between-group difference from Session 1 (baseline) and Session 9 (approximately week 20), estimated with a linear contrast.
Population: All available data were used for the linear contrasts. See Participant Flow for reasons for missing data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| The Behavioral Activation/ Problem Solving Intervention | Occupational Performance | Satisfaction: Session 9 (approximately week 20) | 7.15 score on a scale | Standard Error 0.15 |
| The Behavioral Activation/ Problem Solving Intervention | Occupational Performance | Importance: Session 1 (baseline) | 8.66 score on a scale | Standard Error 0.08 |
| The Behavioral Activation/ Problem Solving Intervention | Occupational Performance | Importance: Session 9 (approximately week 20) | 8.78 score on a scale | Standard Error 0.09 |
| The Behavioral Activation/ Problem Solving Intervention | Occupational Performance | Performance: Session 1 (baseline) | 4.13 score on a scale | Standard Error 0.12 |
| The Behavioral Activation/ Problem Solving Intervention | Occupational Performance | Performance: Session 9 (approximately week 20) | 6.99 score on a scale | Standard Error 0.13 |
| The Behavioral Activation/ Problem Solving Intervention | Occupational Performance | Satisfaction: Session 1 (baseline) | 3.74 score on a scale | Standard Error 0.14 |
| Attention Control Condition | Occupational Performance | Performance: Session 9 (approximately week 20) | 6.3 score on a scale | Standard Error 0.13 |
| Attention Control Condition | Occupational Performance | Satisfaction: Session 9 (approximately week 20) | 6.08 score on a scale | Standard Error 0.15 |
| Attention Control Condition | Occupational Performance | Performance: Session 1 (baseline) | 4.29 score on a scale | Standard Error 0.12 |
| Attention Control Condition | Occupational Performance | Importance: Session 1 (baseline) | 8.87 score on a scale | Standard Error 0.08 |
| Attention Control Condition | Occupational Performance | Satisfaction: Session 1 (baseline) | 3.93 score on a scale | Standard Error 0.14 |
| Attention Control Condition | Occupational Performance | Importance: Session 9 (approximately week 20) | 8.75 score on a scale | Standard Error 0.09 |
p-value: 0.0995% CI: [-0.01, 0.54]Mixed Models Analysis