Metastatic Breast Cancer
Conditions
Keywords
psychotherapy, fatigue, quality of life
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 metastatic breast cancer (MBC) cancer patients. ACT includes mindfulness exercises (e.g., meditations, performing activities with greater awareness), identifying personal values (e.g., family, work), and engaging in activities consistent with these values. A total of 250 patients will be randomly assigned in equal numbers to either the ACT intervention or an education/support condition. Patients in both conditions will participate in six weekly 50-minute telephone sessions. Outcomes will be assessed at baseline, 2 weeks post-intervention, and 3 and 6 months post-intervention. The investigators hypothesize that ACT will lead to improved primary and secondary outcomes as compared to education/support. A demonstration of ACT's efficacy will lead to dissemination of the intervention and ultimately fulfill an unmet need in the comprehensive care of MBC patients.
Detailed description
This trial tests the effect of telephone-based Acceptance and Commitment Therapy (ACT) on fatigue interference in metastatic breast cancer (MBC) patients (Aim 1) as well as secondary outcomes (Aim 2). This trial also examines increases in psychological flexibility as a hypothesized mediator of ACT's effect on fatigue interference (Aim 3). Finally, two core aspects of psychological flexibility (i.e., mindfulness/acceptance and commitment/behavior change processes) are examined as exploratory mediators of ACT's effect on fatigue interference. The study team will recruit MBC patients receiving care through Eskenazi Health or Indiana University (IU) Health. Potentially eligible patients will be mailed an introductory letter signed by their oncologist and the PI along with a consent form. The letter will have a number to call if they do not wish to be contacted further. A research assistant (RA) will call all prospective participants who do not opt out approximately 1 to 2 weeks after the letter is mailed. The RA will describe the study as outlined in the consent form and answer any questions. Then the RA will administer an eligibility screening to those who consent to participate. Eligible and consenting patients will complete a 35-minute baseline phone assessment. Following baseline assessments, MBC patients (N = 250) will be randomly assigned in equal numbers to ACT or education/support using a stratified block randomization scheme to balance the groups by age (\<65 yrs. vs. 65+ yrs.) and performance status (patient-reported Eastern Cooperative Oncology Group \[ECOG\] scores 0 or 1 vs. 2). Patients in both study conditions will complete 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 will be assessed and recorded during each session. Blind interviewers will assess outcomes and potential mediators during 30-minute follow-up phone assessments at 2 weeks, 3 months, and 6 months post-intervention.
Interventions
BEHAVIORALAcceptance and Commitment Therapy
Across six weekly 50-minute sessions, patients in the Acceptance and Commitment Therapy condition will practice various mindfulness exercises, clarify their values, and set specific goals consistent with their values. Sessions will incorporate discussion of patients' cancer experiences. Through in-session and home practice of skills, participants will learn new and more adaptive ways to respond to fatigue. Participants will 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, patients in the education/support condition will discuss their concerns, including symptoms and other cancer-related stressors, with a therapist providing psychological support. The therapist will direct patients to resources for practical and health information and contact information for psychosocial services. Sessions will include an orientation to the patient's medical center, education regarding common cancer-related symptoms and quality-of-life concerns, and an overview of resources for addressing these concerns. The therapist will also describe resources for addressing financial concerns and methods of evaluating health information available via the Internet and other modalities. Participants will receive handouts on session topics and will be asked to review them as homework.
Sponsors
National Cancer Institute (NCI)
Eskenazi Health
Community Health Network
Indiana University Health
Northwestern University
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Metastatic breast cancer patients (N = 250) will be 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 age (\<65 yrs. vs. 65+ yrs.) and performance status (patient-reported Eastern Cooperative Oncology Group \[ECOG\] scores 0 or 1 vs. 2).
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is at least 3 weeks post-diagnosis of stage IV breast cancer and is receiving care at the Indiana University (IU) Simon Cancer Center, Eskenazi Health, IU Health North, IU Health Bloomington, IU Health Ball Memorial, IU Health Portland, IU Health Morgan, IU Health New Castle, IU Health Central-Fishers, another IU Health hospital or clinic, Community Health Network, or the Robert H. Lurie Comprehensive Cancer Center of Northwestern University. * Patient is at least 18 years of age. * Patient has adequate English fluency for completion of data collection. * Patient has moderate to severe fatigue interference with functioning
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. * Male sex
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue Interference Subscale of Fatigue Symptom Inventory | 2 weeks, 3 months, and 6 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Outcomes Measurement Information System (PROMIS) Sleep-related Impairment | 2 weeks, 3 months, and 6 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. |
| PROMIS Ability to Participate in Social Roles and Activities | 2 weeks, 3 months, and 6 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. |
| Functional Assessment of Cancer Therapy-General | 2 weeks, 3 months, and 6 months post-intervention | This 27-item measure evaluates physical, social/family, emotional, and functional quality of life. For each of the 4 subscale scores (i.e., Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being), the items are summed, multiplied by the number of items, and divided by the number of items answered, with higher scores indicating better quality of life. Items are rated on 0 to 4 scales. The physical well-being subscale is the sum of 7 items (all items reverse-coded) with a range of 0 to 28. The social/family well-being subscale is the sum of 7 items (none reverse-coded) with a range of 0 to 28. The emotional well-being subscale is the sum of 6 items (5 items reverse-coded) with a range of 0 to 24. The functional well-being subscale is the sum of 7 items (none reverse-coded) with a range of 0 to 28. This is a secondary outcome measure. |
Countries
United States
Participant flow
Pre-assignment details
14 patients were excluded from the study before assignment to groups. Here is a list of the reasons: Not feeling well/health problems (2), Did not have time (5), Participation was too much work (4), Not interested in the study (1), Not eligible (1), Other (1)
Participants by arm
| Arm | Count |
|---|---|
| Acceptance and Commitment Therapy Patients in the ACT arm will learn new and more adaptive ways to respond to fatigue.
Acceptance and Commitment Therapy: Across six weekly 50-minute sessions, patients in the Acceptance and Commitment Therapy condition will practice various mindfulness exercises, clarify their values, and set specific goals consistent with their values. Sessions will incorporate discussion of patients' cancer experiences. Through in-session and home practice of skills, participants will learn new and more adaptive ways to respond to fatigue. Participants will receive handouts on session topics and a compact disc (CD) that we developed to guide mindfulness practices. | 116 |
| Education/Support Patients in the education/support arm will 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, patients in the education/support condition will discuss their concerns, including symptoms and other cancer-related stressors, with a therapist providing psychological support. The therapist will direct patients to resources for practical and health information and contact information for psychosocial services. Sessions will include an orientation to the patient's medical center, education regarding common cancer-related symptoms and quality-of-life concerns, and an overview of resources for addressing these concerns. The therapist will also describe resources for addressing financial concerns and methods of evaluating health information available via the Internet and other modalities. Participants will receive handouts on session topics and will be asked to review them as homework. | 120 |
| Total | 236 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 7 | 11 |
| Overall Study | hospice enrollment | 3 | 3 |
| Overall Study | Lost to Follow-up | 6 | 6 |
| Overall Study | Not feeling well/health problems | 3 | 5 |
| Overall Study | Withdrawal by Subject | 0 | 4 |
Baseline characteristics
| Characteristic | Acceptance and Commitment Therapy | Education/Support | Total |
|---|---|---|---|
| Age, Continuous | 58.4 years STANDARD_DEVIATION 11.4 | 59.6 years STANDARD_DEVIATION 11.7 | 58.97 years STANDARD_DEVIATION 11.54 |
| Chemotherapy No-chemotherapy not received for breast cancer | 31 Participants | 20 Participants | 51 Participants |
| Chemotherapy Yes-chemotherapy received for breast cancer | 85 Participants | 100 Participants | 185 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 115 Participants | 118 Participants | 233 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Hormonal Therapy No-hormonal therapy not received for breast cancer | 26 Participants | 22 Participants | 48 Participants |
| Hormonal Therapy Yes-hormonal therapy received for breast cancer | 90 Participants | 98 Participants | 188 Participants |
| Household income $0 to $50,999 | 45 Participants | 46 Participants | 91 Participants |
| Household income $100,000 or more | 33 Participants | 33 Participants | 66 Participants |
| Household income $51,000 to $99,999 | 29 Participants | 35 Participants | 64 Participants |
| Household income Missing data | 9 Participants | 6 Participants | 15 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 16 Participants | 24 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 | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 107 Participants | 103 Participants | 210 Participants |
| Radiation No-radiation not received for breast cancer | 23 Participants | 30 Participants | 53 Participants |
| Radiation Yes-radiation received for breast cancer | 93 Participants | 90 Participants | 183 Participants |
| Region of Enrollment United States | 116 Participants | 120 Participants | 236 Participants |
| Sex: Female, Male Female | 116 Participants | 120 Participants | 236 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Targeted Therapy No-targeted therapy not received for breast cancer | 79 Participants | 84 Participants | 163 Participants |
| Targeted Therapy Yes-targeted therapy received for breast cancer | 37 Participants | 36 Participants | 73 Participants |
| Time since stage IV breast cancer diagnosis | 2.75 years STANDARD_DEVIATION 3.62 | 2.94 years STANDARD_DEVIATION 3.72 | 2.85 years STANDARD_DEVIATION 3.67 |
| Years of education | 15.3 years STANDARD_DEVIATION 2.38 | 15.2 years STANDARD_DEVIATION 2.73 | 15.27 years STANDARD_DEVIATION 2.56 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 7 / 116 | 11 / 120 |
| other Total, other adverse events | 0 / 116 | 0 / 120 |
| serious Total, serious adverse events | 7 / 116 | 11 / 120 |
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.
Time frame: 2 weeks, 3 months, and 6 months post-intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acceptance and Commitment Therapy | Fatigue Interference Subscale of Fatigue Symptom Inventory | Fatigue interference at 2 weeks post-intervention | 2.96 units on a scale | Standard Deviation 1.9 |
| Acceptance and Commitment Therapy | Fatigue Interference Subscale of Fatigue Symptom Inventory | Fatigue interference at 3 months post-intervention | 3.24 units on a scale | Standard Deviation 2.05 |
| Acceptance and Commitment Therapy | Fatigue Interference Subscale of Fatigue Symptom Inventory | Fatigue interference at 6 months post-intervention | 3.08 units on a scale | Standard Deviation 2.32 |
| Education/Support | Fatigue Interference Subscale of Fatigue Symptom Inventory | Fatigue interference at 2 weeks post-intervention | 3.66 units on a scale | Standard Deviation 2.2 |
| Education/Support | Fatigue Interference Subscale of Fatigue Symptom Inventory | Fatigue interference at 3 months post-intervention | 3.43 units on a scale | Standard Deviation 2.25 |
| Education/Support | Fatigue Interference Subscale of Fatigue Symptom Inventory | Fatigue interference at 6 months post-intervention | 3.64 units on a scale | Standard Deviation 2.26 |
p-value: 0.01895% CI: [-0.01, 0.25]Mixed Models Analysis
Secondary
Functional Assessment of Cancer Therapy-General
This 27-item measure evaluates physical, social/family, emotional, and functional quality of life. For each of the 4 subscale scores (i.e., Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being), the items are summed, multiplied by the number of items, and divided by the number of items answered, with higher scores indicating better quality of life. Items are rated on 0 to 4 scales. The physical well-being subscale is the sum of 7 items (all items reverse-coded) with a range of 0 to 28. The social/family well-being subscale is the sum of 7 items (none reverse-coded) with a range of 0 to 28. The emotional well-being subscale is the sum of 6 items (5 items reverse-coded) with a range of 0 to 24. The functional well-being subscale is the sum of 7 items (none reverse-coded) with a range of 0 to 28. This is a secondary outcome measure.
Time frame: 2 weeks, 3 months, and 6 months post-intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acceptance and Commitment Therapy | Functional Assessment of Cancer Therapy-General | Physical quality of life at 2 weeks post-intervention | 17.73 units on a scale | Standard Deviation 5.06 |
| Acceptance and Commitment Therapy | Functional Assessment of Cancer Therapy-General | Physical quality of life at 3 months post-intervention | 17.34 units on a scale | Standard Deviation 5.8 |
| Acceptance and Commitment Therapy | Functional Assessment of Cancer Therapy-General | Physical quality of life at 6 months post-intervention | 17.18 units on a scale | Standard Deviation 6.05 |
| Acceptance and Commitment Therapy | Functional Assessment of Cancer Therapy-General | Social/family quality of life at 2 weeks post-intervention | 21.15 units on a scale | Standard Deviation 4.71 |
| Acceptance and Commitment Therapy | Functional Assessment of Cancer Therapy-General | Social/family quality of life at 3 months post-intervention | 20.39 units on a scale | Standard Deviation 5.38 |
| Acceptance and Commitment Therapy | Functional Assessment of Cancer Therapy-General | Social/family quality of life at 6 months post-intervention | 20.36 units on a scale | Standard Deviation 5.05 |
| Acceptance and Commitment Therapy | Functional Assessment of Cancer Therapy-General | Emotional quality of life at 2 weeks post-intervention | 16.72 units on a scale | Standard Deviation 4.2 |
| Acceptance and Commitment Therapy | Functional Assessment of Cancer Therapy-General | Emotional quality of life at 3 months post-intervention | 16.42 units on a scale | Standard Deviation 4.53 |
| Acceptance and Commitment Therapy | Functional Assessment of Cancer Therapy-General | Emotional quality of life at 6 months post-intervention | 16.21 units on a scale | Standard Deviation 4.84 |
| Acceptance and Commitment Therapy | Functional Assessment of Cancer Therapy-General | Functional quality of life at 2 weeks post-intervention | 17.84 units on a scale | Standard Deviation 4.53 |
| Acceptance and Commitment Therapy | Functional Assessment of Cancer Therapy-General | Functional quality of life at 3 months post-intervention | 17.18 units on a scale | Standard Deviation 4.9 |
| Acceptance and Commitment Therapy | Functional Assessment of Cancer Therapy-General | Functional quality of life at 6 months post-intervention | 17.47 units on a scale | Standard Deviation 5.43 |
| Education/Support | Functional Assessment of Cancer Therapy-General | Functional quality of life at 3 months post-intervention | 16.85 units on a scale | Standard Deviation 5.36 |
| Education/Support | Functional Assessment of Cancer Therapy-General | Physical quality of life at 2 weeks post-intervention | 16.99 units on a scale | Standard Deviation 5.08 |
| Education/Support | Functional Assessment of Cancer Therapy-General | Emotional quality of life at 2 weeks post-intervention | 16.24 units on a scale | Standard Deviation 4.81 |
| Education/Support | Functional Assessment of Cancer Therapy-General | Physical quality of life at 3 months post-intervention | 16.90 units on a scale | Standard Deviation 6.07 |
| Education/Support | Functional Assessment of Cancer Therapy-General | Functional quality of life at 2 weeks post-intervention | 16.99 units on a scale | Standard Deviation 5.39 |
| Education/Support | Functional Assessment of Cancer Therapy-General | Physical quality of life at 6 months post-intervention | 16.54 units on a scale | Standard Deviation 6.15 |
| Education/Support | Functional Assessment of Cancer Therapy-General | Emotional quality of life at 3 months post-intervention | 16.16 units on a scale | Standard Deviation 4.92 |
| Education/Support | Functional Assessment of Cancer Therapy-General | Social/family quality of life at 2 weeks post-intervention | 20.58 units on a scale | Standard Deviation 5.47 |
| Education/Support | Functional Assessment of Cancer Therapy-General | Functional quality of life at 6 months post-intervention | 16.68 units on a scale | Standard Deviation 5.28 |
| Education/Support | Functional Assessment of Cancer Therapy-General | Social/family quality of life at 3 months post-intervention | 20.71 units on a scale | Standard Deviation 5.49 |
| Education/Support | Functional Assessment of Cancer Therapy-General | Emotional quality of life at 6 months post-intervention | 16.79 units on a scale | Standard Deviation 5.01 |
| Education/Support | Functional Assessment of Cancer Therapy-General | Social/family quality of life at 6 months post-intervention | 20.72 units on a scale | Standard Deviation 6.34 |
p-value: 0.16795% CI: [-0.04, 0.21]Mixed Models Analysis
p-value: 0.10595% CI: [-0.03, 0.22]Mixed Models Analysis
p-value: 0.14295% CI: [-0.04, 0.22]Mixed Models Analysis
p-value: 0.00695% CI: [0.01, 0.26]Mixed Models Analysis
Secondary
Patient Reported Outcomes 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.
Time frame: 2 weeks, 3 months, and 6 months post-intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acceptance and Commitment Therapy | Patient Reported Outcomes Measurement Information System (PROMIS) Sleep-related Impairment | Sleep-related impairment at 2 weeks post-intervention | 55.28 T-score | Standard Deviation 4.22 |
| Acceptance and Commitment Therapy | Patient Reported Outcomes Measurement Information System (PROMIS) Sleep-related Impairment | Sleep-related impairment at 3 months post-intervention | 54.27 T-score | Standard Deviation 7.79 |
| Acceptance and Commitment Therapy | Patient Reported Outcomes Measurement Information System (PROMIS) Sleep-related Impairment | Sleep-related impairment at 6 months post-intervention | 54.05 T-score | Standard Deviation 7.95 |
| Education/Support | Patient Reported Outcomes Measurement Information System (PROMIS) Sleep-related Impairment | Sleep-related impairment at 2 weeks post-intervention | 56.26 T-score | Standard Deviation 4.27 |
| Education/Support | Patient Reported Outcomes Measurement Information System (PROMIS) Sleep-related Impairment | Sleep-related impairment at 3 months post-intervention | 54.62 T-score | Standard Deviation 8.91 |
| Education/Support | Patient Reported Outcomes Measurement Information System (PROMIS) Sleep-related Impairment | Sleep-related impairment at 6 months post-intervention | 54.78 T-score | Standard Deviation 8.72 |
p-value: 0.03795% CI: [-0.02, 0.24]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.
Time frame: 2 weeks, 3 months, and 6 months post-intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Acceptance and Commitment Therapy | PROMIS Ability to Participate in Social Roles and Activities | Ability to participate in social roles and activities at 2 weeks post-intervention | 46.75 T-score | Standard Deviation 6.79 |
| Acceptance and Commitment Therapy | PROMIS Ability to Participate in Social Roles and Activities | Ability to participate in social roles and activities at 3 months post-intervention | 47.49 T-score | Standard Deviation 7.91 |
| Acceptance and Commitment Therapy | PROMIS Ability to Participate in Social Roles and Activities | Ability to participate in social roles and activities at 6 months post-intervention | 46.81 T-score | Standard Deviation 8.17 |
| Education/Support | PROMIS Ability to Participate in Social Roles and Activities | Ability to participate in social roles and activities at 2 weeks post-intervention | 46.66 T-score | Standard Deviation 6.86 |
| Education/Support | PROMIS Ability to Participate in Social Roles and Activities | Ability to participate in social roles and activities at 3 months post-intervention | 46.75 T-score | Standard Deviation 8.56 |
| Education/Support | PROMIS Ability to Participate in Social Roles and Activities | Ability to participate in social roles and activities at 6 months post-intervention | 46.10 T-score | Standard Deviation 8.01 |
p-value: 0.35595% CI: [-0.06, 0.2]Mixed Models Analysis