Gastrointestinal Neoplasms
Conditions
Keywords
Acceptance and Commitment Therapy, Fatigue, Family Caregivers, Psychotherapy
Brief summary
This trial tests telephone-based Acceptance and Commitment Therapy (ACT), a type of psychotherapy, to reduce fatigue interference with activities, mood, and cognition in advanced gastrointestinal (GI) cancer patients and family caregiver burden. ACT includes mindfulness exercises (e.g., meditations, performing activities with greater awareness), identifying personal values (e.g., family, spirituality), and engaging in activities consistent with these values. A total of 40 patient-caregiver dyads were randomly assigned in equal numbers to either the ACT intervention or an education/support condition. Dyads in both conditions participated in six weekly 50-minute telephone sessions. Outcomes were assessed at baseline, 2 weeks post-intervention, and 3 months post-intervention. The investigators hypothesize that ACT will lead to improved primary and secondary outcomes as compared to education/support. Study findings will inform a large-scale trial of intervention efficacy.
Detailed description
This trial evaluates the feasibility, acceptability, and preliminary efficacy of telephone-based Acceptance and Commitment Therapy (ACT) on fatigue interference in advanced gastrointestinal (GI) cancer patients and family caregiver burden as well as secondary outcomes. The study team recruited advanced GI cancer patients receiving care at the Indiana University Simon Cancer Center or Eskenazi Health hospital. Potentially eligible patients were mailed an introductory letter signed by their oncologist and the PI along with a consent form. The letter had a number to call if they did not wish to be contacted further. A research assistant (RA) called all prospective participants who did not opt out approximately 1 to 2 weeks after the letter was mailed. The RA described the study as outlined in the consent form and answered any questions. Then the RA administered an eligibility screening to those who consented to participate. Eligible and consenting patients identified a potentially eligible family caregiver. If the family caregiver was eligible and consented to participate, then the patient and caregiver each completed a baseline phone assessment. Following baseline assessments, patient-caregiver dyads (N = 40 dyads) were randomly assigned in equal numbers to ACT or education/support using a stratified block randomization scheme to balance the groups by patient performance status (patient-reported Eastern Cooperative Oncology Group \[ECOG\] scores 0 or 1 vs. 2). Dyads in both study conditions completed six weekly 50-minute telephone sessions with the first session occurring one week after baseline. For ACT participants, adherence to home practice during the past week was assessed and recorded during each session. Feasibility will be examined via accrual, attrition, and adherence rates, and acceptability will be evaluated using a mixed methods approach (qualitative and quantitative). Blind interviewers assessed outcomes during follow-up phone assessments at 2 weeks and 3 months post-intervention.
Interventions
BEHAVIORALAcceptance and Commitment Therapy
Across six weekly 50-minute sessions, advanced GI cancer patients and caregivers practice various mindfulness exercises, clarify their values, and set specific goals in alignment with their values. Through in-session and home practice of skills, participants learn new and more adaptive ways to respond to unwanted internal experiences (e.g., fatigue, distress). Participants receive handouts on session topics and a compact disc (CD) that we developed to guide mindfulness practices.
BEHAVIORALEducation/Support
Across six weekly 50-minute sessions, advanced GI cancer patients and caregivers are directed to resources for practical and health information and contact information for psychosocial services. Sessions include an orientation to the patient's medical center and treatment team, education regarding common quality-of-life concerns experienced by cancer patients and caregivers, and an overview of medical center and community resources for addressing these concerns. The therapist also describes resources for addressing financial concerns and methods of evaluating health information available via the Internet and other modalities. Participants receive handouts summarizing session topics and are asked to review them as homework.
Sponsors
National Cancer Institute (NCI)
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Advanced gastrointestinal cancer patient-family caregiver dyads (N = 40) were randomly assigned in equal numbers to Acceptance and Commitment Therapy (ACT) or education/support using a stratified block randomization scheme to balance the groups by patient performance status (patient-reported Eastern Cooperative Oncology Group \[ECOG\] scores 0 or 1 vs. 2).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient Inclusion Criteria: * Patient is at least 3 weeks post-diagnosis of unresectable stage III or stage IV gastrointestinal cancer (i.e., anal, colon, esophageal, gallbladder, liver, pancreatic, rectal, small intestine, or stomach cancer) and is receiving care at the Indiana University Simon Cancer Center or Eskenazi Health. * Patient is at least 21 years of age. * Patient can speak and read English. * Patient has an eligible, consenting family caregiver (see criteria below). * Patient has moderate to severe fatigue interference with functioning. Patient
Exclusion criteria
* Patient shows significant psychiatric or cognitive impairment that would preclude providing informed consent and study participation. * Patient reports being able to do little activity on a functional status measure. * Patient is receiving hospice care at screening. * Patient does not have working phone service. * Patient has hearing impairment that precludes participation. Caregiver Inclusion Criteria: * Family caregiver identified by a stage IV gastrointestinal cancer patient who meets the eligibility criteria. * Caregiver has significant caregiving burden or distress * Caregiver lives with the patient or has visited the patient in-person at least twice a week for the past month. * Caregiver is at least 18 years of age. * Caregiver can speak and read English. Caregiver
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue Interference Subscale of Fatigue Symptom Inventory | 2 weeks and 3 months post-intervention | Seven items are rated on 11-point scales (0=no interference to 10=extreme interference) that assess the extent to which fatigue in the past week interfered with general level of activity, ability to bathe and dress, normal work activity (including housework), ability to concentrate, relations with others, enjoyment of life, and mood. The seven items are summed with higher total scores indicating greater fatigue interference. The total score range is 0 to 70. This is the primary outcome for patients. |
| Short-form of Zarit Burden Interview | 2 weeks and 3 months post-intervention | Twelve items are rated on 5-point scales (0=never to 4=nearly always) that assess personal strain and role strain due to caregiving. The 12 items are summed with higher total scores indicating greater caregiving burden. The total score range is 0 to 48. This is the primary outcome for caregivers. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptance and Action Questionnaire-II | 2 weeks and 3 months post-intervention | This 7-item measure assesses psychological flexibility, or the ability to fully experience the present moment while persisting in actions aligned with personal values. Each item is rated on a scale from 1 (never true) to 7 (always true). The seven items are summed with higher total scores indicating greater levels of psychological inflexibility. The total score range is 7 to 49. This is a secondary outcome for both patients and caregivers. |
| McGill Quality of Life Questionnaire-Revised | 2 weeks and 3 months post-intervention | This 15-item measure evaluates physical, psychological, existential, and social quality of life in patients with serious illnesses. Each of the 4 subscale scores (i.e., physical, psychological, existential, and social quality of life) is the sum of the items with higher scores indicating better quality of life. Items are rated on 0 to 10 scales. The physical quality of life subscale is the sum of 3 items (2 items reverse-coded) with a range of 0 to 30. The psychological quality of life subscale is the sum of 4 items (all items reverse-coded) with a range of 0 to 40. The existential quality of life subscale is the sum of 4 items (1 item reverse-coded) with a range of 0 to 40. The social quality of life subscale is the sum of 3 items (none reverse-coded) with a range of 0 to 30. This is a secondary outcome measure for patients. |
| Patient-Reported Outcome Measurement Information System (PROMIS) Sleep-Related Impairment | 2 weeks and 3 months post-intervention | This 8-item measure assesses the perceived interference of sleep problems with activities, mood, and cognition (e.g., difficulty concentrating or completing tasks). Each item is rated on a scale from 1 (not at all) to 5 (very much). Item #2 is reverse-scored and then the 8 items are summed with higher total scores indicating greater sleep-related impairment. The total scores are converted to T-scores with a range from 30.0 to 80.1. Higher T-scores indicate a worse outcome. The population mean for T-scores is 50 with a standard deviation of 10. This is a secondary outcome for patients. |
| Value Progress Subscale of the Valuing Questionnaire. | 2 weeks and 3 months post-intervention | This 5-item subscale assesses progress in living according to one's personal values, a construct related to activity engagement. Items are rated on 0 to 6 scales. The 5 items are summed with higher total subscale scores indicating greater progress in living according to one's personal values. The total subscale score range is 0 to 30. This is a secondary outcome measure for patients and caregivers. |
| PROMIS Global Health | 2 weeks and 3 months post-intervention | This 10-item measure assesses global health, including physical, mental, and social well-being. With the exception of pain, which is rated on a 0 to 10 scale, all items are rated on 5-point scales from 1 to 5. The item on pain is recoded from a 0-10 to a 1-5 scale and reverse-scored. Two additional items are reverse-scored. Then four of the items are summed, with higher physical quality of life subscale scores indicating better physical quality of life. Four other items are also summed with higher psychological quality of life subscale scores indicating better psychological quality of life. The subscale scores are converted to T-scores with a range from 16.2 to 67.7 for physical quality of life and a range from 21.2 to 67.6 for psychological quality of life. Higher T-scores for the physical and psychological quality of life subscales indicate a better outcome. The population mean for T-scores is 50 with a standard deviation of 10. This is a secondary outcome measure for caregivers. |
| PROMIS Ability to Participate in Social Roles and Activities | 2 weeks and 3 months post-intervention | This 6-item measure assesses participants' ability to participate in social roles and activities. The items measure difficulty engaging in social and recreational activities as well as usual work (including housework). Each item is rated on a scale from 1 (never) to 5 (always) and is reverse coded. Then the six items are summed with higher total scores indicating greater ability to participate in social roles and activities. The total scores are converted to T-scores with a range from 26.7 to 65.0 with higher scores indicating a better outcome. The population mean for T-scores is 50 with a standard deviation of 10. This is a secondary outcome for both patients and caregivers. |
Countries
United States
Participant flow
Pre-assignment details
2 patients and 2 caregivers were excluded from the study before assignment to groups. Here is a list of the reasons: Patient death (1) Caregiver withdrew because patient died (1) Patient lost to follow-up (1) Caregiver withdrew because patient was lost to follow-up (1)
Participants by arm
| Arm | Count |
|---|---|
| Acceptance and Commitment Therapy Patients and caregivers in the ACT arm learn new and more adaptive ways to respond to difficult internal experiences (e.g., fatigue, thoughts, and feelings).
Acceptance and Commitment Therapy: Across six weekly 50-minute sessions, advanced GI cancer patients and caregivers practice various mindfulness exercises, clarify their values, and set specific goals in alignment with their values. Through in-session and home practice of skills, participants learn new and more adaptive ways to respond to unwanted internal experiences (e.g., fatigue, distress). Participants receive handouts on session topics and a CD that we developed to guide mindfulness practices. | 40 |
| Education/Support Patients and caregivers in the education/support arm discuss their cancer-related concerns and receive education on services available in their medical center and community.
Education/Support: Across six weekly 50-minute sessions, advanced GI cancer patients and caregivers are directed to resources for practical and health information and contact information for psychosocial services. Sessions include an orientation to the patient's medical center and treatment team, education regarding common quality-of-life concerns experienced by cancer patients and caregivers, and an overview of medical center and community resources for addressing these concerns. The therapist also describes resources for addressing financial concerns and methods of evaluating health information available via the Internet and other modalities. Participants receive handouts summarizing session topics and are asked to review them as homework. | 40 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Caregiver withdrawn because patient was withdrawn for any reason | 5 | 5 |
| Overall Study | Death | 1 | 2 |
| Overall Study | Medical Reasons | 4 | 3 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Acceptance and Commitment Therapy | Education/Support | Total |
|---|---|---|---|
| Age, Continuous Caregiver age | 55.55 years STANDARD_DEVIATION 14.87 | 48.60 years STANDARD_DEVIATION 15.8 | 52.08 years STANDARD_DEVIATION 15.55 |
| Age, Continuous Patient age | 59.25 years STANDARD_DEVIATION 9.96 | 57.85 years STANDARD_DEVIATION 15.71 | 58.55 years STANDARD_DEVIATION 13 |
| Caregiver lives with the patient No, caregiver does not live with the patient. | 5 Participants | 5 Participants | 10 Participants |
| Caregiver lives with the patient Yes, caregiver lives with the patient. | 15 Participants | 15 Participants | 30 Participants |
| Caregiver's relationship to the patient Other family member | 8 Participants | 7 Participants | 15 Participants |
| Caregiver's relationship to the patient Spouse or partner | 12 Participants | 13 Participants | 25 Participants |
| Chemoradiation No-chemoradiation not received for gastrointestinal cancer | 15 Participants | 16 Participants | 31 Participants |
| Chemoradiation Yes-chemoradiation received for gastrointestinal cancer | 5 Participants | 4 Participants | 9 Participants |
| Chemotherapy No-chemotherapy not received for gastrointestinal cancer | 5 Participants | 3 Participants | 8 Participants |
| Chemotherapy Yes-chemotherapy received for gastrointestinal cancer | 15 Participants | 17 Participants | 32 Participants |
| Education Caregiver education | 15.23 years STANDARD_DEVIATION 2.67 | 15.45 years STANDARD_DEVIATION 2.61 | 15.34 years STANDARD_DEVIATION 2.61 |
| Education Patient education | 15.48 years STANDARD_DEVIATION 2.66 | 14.70 years STANDARD_DEVIATION 2.45 | 15.09 years STANDARD_DEVIATION 2.56 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 40 Participants | 40 Participants | 80 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Fatigue Interference Subscale of Fatigue Symptom Inventory | 4.25 units on a scale STANDARD_DEVIATION 1.86 | 3.58 units on a scale STANDARD_DEVIATION 1.92 | 3.91 units on a scale STANDARD_DEVIATION 1.9 |
| Household income Caregiver income $0-$50,999 | 5 Participants | 6 Participants | 11 Participants |
| Household income Caregiver income $100,000 or more | 6 Participants | 9 Participants | 15 Participants |
| Household income Caregiver income $51,000-$99,999 | 9 Participants | 5 Participants | 14 Participants |
| Household income Caregiver income Missing data | 0 Participants | 0 Participants | 0 Participants |
| Household income Patient income $0-$50,999 | 5 Participants | 7 Participants | 12 Participants |
| Household income Patient income $100,000 or more | 10 Participants | 9 Participants | 19 Participants |
| Household income Patient income $51,000-$99,999 | 5 Participants | 3 Participants | 8 Participants |
| Household income Patient income Missing data | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Caregiver race American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregiver race Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregiver race Black or African American | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Caregiver race More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregiver race Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregiver race Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Caregiver race White | 18 Participants | 19 Participants | 37 Participants |
| Race (NIH/OMB) Patient race American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Patient race Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Patient race Black or African American | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Patient race More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Patient race Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Patient race Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Patient race White | 19 Participants | 19 Participants | 38 Participants |
| Radiation No-radiation not received for gastrointestinal cancer | 18 Participants | 14 Participants | 32 Participants |
| Radiation Yes-radiation received for gastrointestinal cancer | 2 Participants | 6 Participants | 8 Participants |
| Sex: Female, Male Caregiver age Female | 3 Participants | 7 Participants | 10 Participants |
| Sex: Female, Male Caregiver age Male | 17 Participants | 13 Participants | 30 Participants |
| Sex: Female, Male Patient age Female | 10 Participants | 8 Participants | 18 Participants |
| Sex: Female, Male Patient age Male | 10 Participants | 12 Participants | 22 Participants |
| Short-Form of Zarit Burden Interview | 15.85 units on a scale STANDARD_DEVIATION 3.82 | 18.45 units on a scale STANDARD_DEVIATION 8.52 | 17.15 units on a scale STANDARD_DEVIATION 6.65 |
| Surgery to remove metastases No--did not receive surgery to remove metastases | 13 Participants | 16 Participants | 29 Participants |
| Surgery to remove metastases Yes-received surgery to remove metastases | 7 Participants | 4 Participants | 11 Participants |
| Surgery to remove primary tumor No-surgery not received to remove primary tumor | 8 Participants | 9 Participants | 17 Participants |
| Surgery to remove primary tumor Yes-surgery received to remove primary tumor | 12 Participants | 11 Participants | 23 Participants |
| Targeted Therapy No, did not receive targeted therapy for gastrointestinal cancer | 11 Participants | 15 Participants | 26 Participants |
| Targeted Therapy Yes, received targeted therapy for gastrointestinal cancer | 9 Participants | 5 Participants | 14 Participants |
| Time since gastrointestinal cancer diagnosis | 2.40 years STANDARD_DEVIATION 2.36 | 1.67 years STANDARD_DEVIATION 3.3 | 2.04 years STANDARD_DEVIATION 2.85 |
| Type of gastrointestinal cancer Colorectal cancer | 10 Participants | 6 Participants | 16 Participants |
| Type of gastrointestinal cancer Other gastrointestinal cancer | 7 Participants | 7 Participants | 14 Participants |
| Type of gastrointestinal cancer Pancreatic cancer | 3 Participants | 7 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 20 | 2 / 20 | 1 / 22 |
| other Total, other adverse events | 0 / 20 | 0 / 20 | 0 / 22 |
| serious Total, serious adverse events | 1 / 20 | 2 / 20 | 1 / 22 |
Outcome results
Primary
Fatigue Interference Subscale of Fatigue Symptom Inventory
Seven items are rated on 11-point scales (0=no interference to 10=extreme interference) that assess the extent to which fatigue in the past week interfered with general level of activity, ability to bathe and dress, normal work activity (including housework), ability to concentrate, relations with others, enjoyment of life, and mood. The seven items are summed with higher total scores indicating greater fatigue interference. The total score range is 0 to 70. This is the primary outcome for patients.
Time frame: 2 weeks and 3 months post-intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acceptance and Commitment Therapy | Fatigue Interference Subscale of Fatigue Symptom Inventory | Patient fatigue interference at 2 weeks post-intervention | 3.93 units on a scale | Standard Deviation 2.17 |
| Acceptance and Commitment Therapy | Fatigue Interference Subscale of Fatigue Symptom Inventory | Patient fatigue interference at 3 months post-intervention | 4.27 units on a scale | Standard Deviation 1.66 |
| Education/Support | Fatigue Interference Subscale of Fatigue Symptom Inventory | Patient fatigue interference at 2 weeks post-intervention | 3.47 units on a scale | Standard Deviation 2.54 |
| Education/Support | Fatigue Interference Subscale of Fatigue Symptom Inventory | Patient fatigue interference at 3 months post-intervention | 4.26 units on a scale | Standard Deviation 2.12 |
p-value: 0.695% CI: [-0.23, 0.4]Mixed Models Analysis
Primary
Short-form of Zarit Burden Interview
Twelve items are rated on 5-point scales (0=never to 4=nearly always) that assess personal strain and role strain due to caregiving. The 12 items are summed with higher total scores indicating greater caregiving burden. The total score range is 0 to 48. This is the primary outcome for caregivers.
Time frame: 2 weeks and 3 months post-intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acceptance and Commitment Therapy | Short-form of Zarit Burden Interview | Caregiver burden at 2 weeks post-intervention | 13.92 units on a scale | Standard Deviation 3.86 |
| Acceptance and Commitment Therapy | Short-form of Zarit Burden Interview | Caregiver burden at 3 months post-intervention | 15.32 units on a scale | Standard Deviation 4.59 |
| Education/Support | Short-form of Zarit Burden Interview | Caregiver burden at 2 weeks post-intervention | 16.37 units on a scale | Standard Deviation 7.1 |
| Education/Support | Short-form of Zarit Burden Interview | Caregiver burden at 3 months post-intervention | 18.17 units on a scale | Standard Deviation 8.36 |
p-value: 0.9695% CI: [-0.29, 0.34]Mixed Models Analysis
Secondary
Acceptance and Action Questionnaire-II
This 7-item measure assesses psychological flexibility, or the ability to fully experience the present moment while persisting in actions aligned with personal values. Each item is rated on a scale from 1 (never true) to 7 (always true). The seven items are summed with higher total scores indicating greater levels of psychological inflexibility. The total score range is 7 to 49. This is a secondary outcome for both patients and caregivers.
Time frame: 2 weeks and 3 months post-intervention
Population: Number analyzed = 20 patients and 20 caregivers in the Acceptance and Commitment Therapy arm and 20 patients and 20 caregivers in the Education/Support arm
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acceptance and Commitment Therapy | Acceptance and Action Questionnaire-II | Patient psychological inflexibility at 2 weeks post-intervention | 13.82 units on a scale | Standard Deviation 4.98 |
| Acceptance and Commitment Therapy | Acceptance and Action Questionnaire-II | Patient psychological inflexibility at 3 months post-intervention | 13.85 units on a scale | Standard Deviation 6.04 |
| Acceptance and Commitment Therapy | Acceptance and Action Questionnaire-II | Caregiver psychological inflexibility at 2 weeks post-intervention | 17.77 units on a scale | Standard Deviation 6.45 |
| Acceptance and Commitment Therapy | Acceptance and Action Questionnaire-II | Caregiver psychological inflexibility at 3 months post-intervention | 17.58 units on a scale | Standard Deviation 6.21 |
| Education/Support | Acceptance and Action Questionnaire-II | Caregiver psychological inflexibility at 3 months post-intervention | 17.79 units on a scale | Standard Deviation 6.41 |
| Education/Support | Acceptance and Action Questionnaire-II | Patient psychological inflexibility at 2 weeks post-intervention | 14.52 units on a scale | Standard Deviation 6.45 |
| Education/Support | Acceptance and Action Questionnaire-II | Caregiver psychological inflexibility at 2 weeks post-intervention | 17.45 units on a scale | Standard Deviation 8.22 |
| Education/Support | Acceptance and Action Questionnaire-II | Patient psychological inflexibility at 3 months post-intervention | 15.97 units on a scale | Standard Deviation 5.61 |
p-value: 0.9195% CI: [-0.29, 0.34]Mixed Models Analysis
Secondary
McGill Quality of Life Questionnaire-Revised
This 15-item measure evaluates physical, psychological, existential, and social quality of life in patients with serious illnesses. Each of the 4 subscale scores (i.e., physical, psychological, existential, and social quality of life) is the sum of the items with higher scores indicating better quality of life. Items are rated on 0 to 10 scales. The physical quality of life subscale is the sum of 3 items (2 items reverse-coded) with a range of 0 to 30. The psychological quality of life subscale is the sum of 4 items (all items reverse-coded) with a range of 0 to 40. The existential quality of life subscale is the sum of 4 items (1 item reverse-coded) with a range of 0 to 40. The social quality of life subscale is the sum of 3 items (none reverse-coded) with a range of 0 to 30. This is a secondary outcome measure for patients.
Time frame: 2 weeks and 3 months post-intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acceptance and Commitment Therapy | McGill Quality of Life Questionnaire-Revised | Patient physical quality of life at 2 weeks post-intervention | 17.30 units on a scale | Standard Deviation 6.34 |
| Acceptance and Commitment Therapy | McGill Quality of Life Questionnaire-Revised | Patient physical quality of life at 3 months post-intervention | 13.48 units on a scale | Standard Deviation 5.4 |
| Acceptance and Commitment Therapy | McGill Quality of Life Questionnaire-Revised | Patient psychological quality of life at 2 weeks post-intervention | 28.58 units on a scale | Standard Deviation 8.31 |
| Acceptance and Commitment Therapy | McGill Quality of Life Questionnaire-Revised | Patient psychological quality of life at 3 months post-intervention | 28.66 units on a scale | Standard Deviation 8.36 |
| Acceptance and Commitment Therapy | McGill Quality of Life Questionnaire-Revised | Patient existential quality of life at 2 weeks post-intervention | 28.18 units on a scale | Standard Deviation 5.35 |
| Acceptance and Commitment Therapy | McGill Quality of Life Questionnaire-Revised | Patient existential quality of life at 3 months post-intervention | 28.25 units on a scale | Standard Deviation 4.57 |
| Acceptance and Commitment Therapy | McGill Quality of Life Questionnaire-Revised | Patient social quality of life at 2 weeks post-intervention | 24.59 units on a scale | Standard Deviation 5.18 |
| Acceptance and Commitment Therapy | McGill Quality of Life Questionnaire-Revised | Patient social quality of life at 3 months post-intervention | 25.28 units on a scale | Standard Deviation 4.3 |
| Education/Support | McGill Quality of Life Questionnaire-Revised | Patient social quality of life at 3 months post-intervention | 25.64 units on a scale | Standard Deviation 3.51 |
| Education/Support | McGill Quality of Life Questionnaire-Revised | Patient physical quality of life at 2 weeks post-intervention | 16.89 units on a scale | Standard Deviation 6.2 |
| Education/Support | McGill Quality of Life Questionnaire-Revised | Patient existential quality of life at 2 weeks post-intervention | 28.15 units on a scale | Standard Deviation 5.06 |
| Education/Support | McGill Quality of Life Questionnaire-Revised | Patient physical quality of life at 3 months post-intervention | 14.80 units on a scale | Standard Deviation 6.33 |
| Education/Support | McGill Quality of Life Questionnaire-Revised | Patient social quality of life at 2 weeks post-intervention | 24.80 units on a scale | Standard Deviation 5.32 |
| Education/Support | McGill Quality of Life Questionnaire-Revised | Patient psychological quality of life at 2 weeks post-intervention | 29.98 units on a scale | Standard Deviation 5.99 |
| Education/Support | McGill Quality of Life Questionnaire-Revised | Patient existential quality of life at 3 months post-intervention | 27.15 units on a scale | Standard Deviation 4.83 |
| Education/Support | McGill Quality of Life Questionnaire-Revised | Patient psychological quality of life at 3 months post-intervention | 26.09 units on a scale | Standard Deviation 8.27 |
p-value: 0.7495% CI: [-0.25, 0.38]Mixed Models Analysis
p-value: 0.2495% CI: [-0.18, 0.45]Mixed Models Analysis
p-value: 0.7895% CI: [-0.26, 0.37]Mixed Models Analysis
p-value: 0.2995% CI: [-0.19, 0.44]Mixed Models Analysis
Secondary
Patient-Reported Outcome Measurement Information System (PROMIS) Sleep-Related Impairment
This 8-item measure assesses the perceived interference of sleep problems with activities, mood, and cognition (e.g., difficulty concentrating or completing tasks). Each item is rated on a scale from 1 (not at all) to 5 (very much). Item #2 is reverse-scored and then the 8 items are summed with higher total scores indicating greater sleep-related impairment. The total scores are converted to T-scores with a range from 30.0 to 80.1. Higher T-scores indicate a worse outcome. The population mean for T-scores is 50 with a standard deviation of 10. This is a secondary outcome for patients.
Time frame: 2 weeks and 3 months post-intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acceptance and Commitment Therapy | Patient-Reported Outcome Measurement Information System (PROMIS) Sleep-Related Impairment | Patient sleep-related impairment at 2 weeks post-intervention | 57.37 T-score | Standard Deviation 4.03 |
| Acceptance and Commitment Therapy | Patient-Reported Outcome Measurement Information System (PROMIS) Sleep-Related Impairment | Patient sleep-related impairment at 3 months post-intervention | 56.91 T-score | Standard Deviation 5.22 |
| Education/Support | Patient-Reported Outcome Measurement Information System (PROMIS) Sleep-Related Impairment | Patient sleep-related impairment at 2 weeks post-intervention | 52.99 T-score | Standard Deviation 8.38 |
| Education/Support | Patient-Reported Outcome Measurement Information System (PROMIS) Sleep-Related Impairment | Patient sleep-related impairment at 3 months post-intervention | 53.86 T-score | Standard Deviation 7.41 |
p-value: 0.7595% CI: [-0.25, 0.38]Mixed Models Analysis
Secondary
PROMIS Ability to Participate in Social Roles and Activities
This 6-item measure assesses participants' ability to participate in social roles and activities. The items measure difficulty engaging in social and recreational activities as well as usual work (including housework). Each item is rated on a scale from 1 (never) to 5 (always) and is reverse coded. Then the six items are summed with higher total scores indicating greater ability to participate in social roles and activities. The total scores are converted to T-scores with a range from 26.7 to 65.0 with higher scores indicating a better outcome. The population mean for T-scores is 50 with a standard deviation of 10. This is a secondary outcome for both patients and caregivers.
Time frame: 2 weeks and 3 months post-intervention
Population: Number analyzed = 20 patients and 20 caregivers in the Acceptance and Commitment Therapy arm and 20 patients and 20 caregivers in the Education/Support arm
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acceptance and Commitment Therapy | PROMIS Ability to Participate in Social Roles and Activities | Patient ability to participate in social roles and activities at 2 weeks post-intervention | 45.02 T-score | Standard Deviation 6.6 |
| Acceptance and Commitment Therapy | PROMIS Ability to Participate in Social Roles and Activities | Patient ability to participate in social roles and activities at 3 months post-intervention | 45.58 T-score | Standard Deviation 6.92 |
| Acceptance and Commitment Therapy | PROMIS Ability to Participate in Social Roles and Activities | Caregiver ability to participate in social roles and activities at 2 weeks post-intervention | 42.56 T-score | Standard Deviation 4.66 |
| Acceptance and Commitment Therapy | PROMIS Ability to Participate in Social Roles and Activities | Caregiver ability to participate in social roles and activities at 3 months post-intervention | 40.34 T-score | Standard Deviation 2.62 |
| Education/Support | PROMIS Ability to Participate in Social Roles and Activities | Caregiver ability to participate in social roles and activities at 3 months post-intervention | 41.04 T-score | Standard Deviation 8.11 |
| Education/Support | PROMIS Ability to Participate in Social Roles and Activities | Patient ability to participate in social roles and activities at 2 weeks post-intervention | 42.42 T-score | Standard Deviation 7.26 |
| Education/Support | PROMIS Ability to Participate in Social Roles and Activities | Caregiver ability to participate in social roles and activities at 2 weeks post-intervention | 40.40 T-score | Standard Deviation 7.05 |
| Education/Support | PROMIS Ability to Participate in Social Roles and Activities | Patient ability to participate in social roles and activities at 3 months post-intervention | 46.14 T-score | Standard Deviation 5.01 |
p-value: 0.3395% CI: [-0.23, 0.4]Mixed Models Analysis
Secondary
PROMIS Global Health
This 10-item measure assesses global health, including physical, mental, and social well-being. With the exception of pain, which is rated on a 0 to 10 scale, all items are rated on 5-point scales from 1 to 5. The item on pain is recoded from a 0-10 to a 1-5 scale and reverse-scored. Two additional items are reverse-scored. Then four of the items are summed, with higher physical quality of life subscale scores indicating better physical quality of life. Four other items are also summed with higher psychological quality of life subscale scores indicating better psychological quality of life. The subscale scores are converted to T-scores with a range from 16.2 to 67.7 for physical quality of life and a range from 21.2 to 67.6 for psychological quality of life. Higher T-scores for the physical and psychological quality of life subscales indicate a better outcome. The population mean for T-scores is 50 with a standard deviation of 10. This is a secondary outcome measure for caregivers.
Time frame: 2 weeks and 3 months post-intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acceptance and Commitment Therapy | PROMIS Global Health | Caregiver physical quality of life at 2 weeks post-intervention | 46.11 T-score | Standard Deviation 6.02 |
| Acceptance and Commitment Therapy | PROMIS Global Health | Caregiver physical quality of life at 3 months post-intervention | 45.58 T-score | Standard Deviation 4.42 |
| Acceptance and Commitment Therapy | PROMIS Global Health | Caregiver psychological quality of life at 2 weeks post-intervention | 45.01 T-score | Standard Deviation 5.11 |
| Acceptance and Commitment Therapy | PROMIS Global Health | Caregiver psychological quality of life at 3 months post-intervention | 43.99 T-score | Standard Deviation 4.5 |
| Education/Support | PROMIS Global Health | Caregiver psychological quality of life at 3 months post-intervention | 43.30 T-score | Standard Deviation 5.9 |
| Education/Support | PROMIS Global Health | Caregiver physical quality of life at 2 weeks post-intervention | 45.34 T-score | Standard Deviation 5.24 |
| Education/Support | PROMIS Global Health | Caregiver psychological quality of life at 2 weeks post-intervention | 43.48 T-score | Standard Deviation 7.48 |
| Education/Support | PROMIS Global Health | Caregiver physical quality of life at 3 months post-intervention | 44.68 T-score | Standard Deviation 3.33 |
p-value: 0.9295% CI: [-0.28, 0.35]Mixed Models Analysis
p-value: 0.7995% CI: [-0.26, 0.37]Mixed Models Analysis
Secondary
Value Progress Subscale of the Valuing Questionnaire.
This 5-item subscale assesses progress in living according to one's personal values, a construct related to activity engagement. Items are rated on 0 to 6 scales. The 5 items are summed with higher total subscale scores indicating greater progress in living according to one's personal values. The total subscale score range is 0 to 30. This is a secondary outcome measure for patients and caregivers.
Time frame: 2 weeks and 3 months post-intervention
Population: Number analyzed = 20 patients and 20 caregivers in the Acceptance and Commitment Therapy arm and 20 patients and 20 caregivers in the Education/Support arm
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acceptance and Commitment Therapy | Value Progress Subscale of the Valuing Questionnaire. | Patient values progress at 2 weeks post-intervention | 21.71 units on a scale | Standard Deviation 3.49 |
| Acceptance and Commitment Therapy | Value Progress Subscale of the Valuing Questionnaire. | Patient values progress at 3 months post-intervention | 22.71 units on a scale | Standard Deviation 3.26 |
| Acceptance and Commitment Therapy | Value Progress Subscale of the Valuing Questionnaire. | Caregiver values progress at 2 weeks post-intervention | 23.05 units on a scale | Standard Deviation 5.39 |
| Acceptance and Commitment Therapy | Value Progress Subscale of the Valuing Questionnaire. | Caregiver values progress at 3 months post-intervention | 22.97 units on a scale | Standard Deviation 2.62 |
| Education/Support | Value Progress Subscale of the Valuing Questionnaire. | Caregiver values progress at 3 months post-intervention | 22.44 units on a scale | Standard Deviation 3.05 |
| Education/Support | Value Progress Subscale of the Valuing Questionnaire. | Patient values progress at 2 weeks post-intervention | 21.30 units on a scale | Standard Deviation 5.29 |
| Education/Support | Value Progress Subscale of the Valuing Questionnaire. | Caregiver values progress at 2 weeks post-intervention | 21.14 units on a scale | Standard Deviation 4.33 |
| Education/Support | Value Progress Subscale of the Valuing Questionnaire. | Patient values progress at 3 months post-intervention | 21.66 units on a scale | Standard Deviation 5.09 |
p-value: 0.9495% CI: [-0.3, 0.34]Mixed Models Analysis