Breast Cancer Survivor, Cancer Related Fatigue
Conditions
Keywords
self-management, problem solving therapy, actigraphy, occupational therapy
Brief summary
This study is testing a program called Maximizing Energy to see if it can help women who have finished breast cancer treatment manage their fatigue. The study has two main goals: 1. Check if the program can be successfully delivered - Researchers will see if women are willing to join and stay in the study, if they follow the program, and if they find it helpful. 2. See if the program works - Researchers will compare Maximizing Energy to a general health education program to see which one helps reduce cancer-related fatigue better. Participant will: 1. Take tests to see if they qualify and to measure their fatigue. 2. Be randomized to receive Maximizing Energy or Health Education Interventions for 6 sessions over the internet 3. After the sessions and again one month later, repeat some tests to see if their fatigue has improved.
Interventions
BEHAVIORALMaximizing Energy Intervention
A licensed occupational therapist will deliver the intervention. The Maximizing Energy program combines problem-solving therapy (PST) and energy conservation education. Participants will participate in 6 virtual once/week sessions for 30 minutes. The introductory session, they will track their fatigue and identify three key fatigue-related problems. In session 2, they will prioritize one problem and practice problem-solving steps. They then implement an action plan and review progress in the next session. If the solution is ineffective, the therapist helps modify it or create a new one. If successful, the participant moves to the next problem. A MAX workbook supports learning, covering intervention details, fatigue education, energy conservation strategies, and problem-solving worksheets. The goal is to help participants apply these strategies to improve daily life and return to work.
BEHAVIORALHealth Education
To control for the effects of interactions with an interventionist, participants in the attention control group will receive the Health Education intervention. The interventionists will review a workbook covering fatigue, energy conservation, healthy eating, exercise, and relaxation. Like the MAX intervention, Health Education will be delivered virtually in weekly 30-minute one-on-one sessions for six weeks. The interventionist provides education on breast cancer-related fatigue, diet, safe physical activities, and energy conservation strategies tailored to individual needs. A workbook will support learning.
Sponsors
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult (18 years and older) pre and post-menopausal female at birth diagnosed with Stages I-IIIa breast cancer, * completed primary treatment for breast cancer (surgery, chemotherapy, radiation) at least 6 months prior to ensure that fatigue is stable and chronic, - moderate to severe fatigue based on score ≥ 4 on the 7-point Fatigue Severity Scale, * able to speak and understand English * has a mobile device that runs on the Apple or Android platform
Exclusion criteria
* major depressive disorder, mania, hypomania, psychosis, or substance abuse in the past 3 months and * disability due to diagnoses other than breast cancer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention in the study | Baseline to Week 11 (4 weeks post-intervention) | The proportion of participants who remain in the study until its completion relative to those initially enrolled. The retention rate will be calculated separately for the Maximizing Energy and Control Groups using the following formula: (number of participants who completed the study/number of participants initially enrolled)X 100 |
| Participant Adherence to treatment: Receipt | Week 7 (post-6-week intervention) | The investigators will collect data on the number of intervention sessions attended by participants |
| Participant Adherence to treatment: Enactment | Week 7(post-6-week intervention) | The investigators will collect interventionist rating of whether participant completed action plan from previous session (3-point scale; 0 = not completed, 2 = plan completed) for the MAX Intervention group only. |
| Participant Satisfaction with Intervention | Week 7(post-6-week intervention) | Client satisfaction is measured using the Client Satisfaction Questionnaire. The Clients Satisfaction Questionnaire is an 8-item assessment of satisfaction with the intervention program, rated on a 4-point scale that ranges from 1 to 4 in each item. Higher scores indicate greater satisfaction with the intervention. |
| Intervention Fidelity | Week 7(post-6-week intervention) | All intervention sessions will be video recorded and a random 20 percent will be rated by independent evaluators trained by the principal investigator. Intervention fidelity for both groups will be assessed using the PST Provider Checklist. The a priori criterion for adequate fidelity was that equal or greater than 80 percent of intervention sessions are rated with equal or greater than 80 percent of adequate fidelity for the MAX Intervention group while less than 20 percent of intervention sessions are rated with equal or lesser than 20 percent of adequate fidelity for the Health Education group. |
| Changes in fatigue | Baseline to Week 11 (4 weeks post-intervention) | The PROMIS® Item Bank v1.0 - Fatigue - Short Form 13a (FACIT-Fatigue) is a 13-item questionnaire designed to assess fatigue levels and their impact on daily activities and quality of life. Each item is scored on a 5-point Likert scale (1 = not at all to 5 = very much), with a total score ranging from 13 to 65. Higher scores indicate greater fatigue, while lower scores suggest less fatigue and better energy levels. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in resilience | Baseline to Week 11 (4 weeks post-intervention) | The Connor-Davidson Resilience Scale (CD-RISC) is a tool designed to measure an individual's resilience, or ability to adapt to stress and adversity. It consists of 25 items, each rated on a 5-point Likert scale (0 = not true at all to 4 = true nearly all the time), with total scores ranging from 0 to 100. Higher scores indicate greater resilience, reflecting stronger coping skills and adaptability in challenging situations. |
| Changes in impact of fatigue in daily life | Baseline to Week 11 (4 weeks post-intervention) | The Modified Fatigue Impact Scale (MFIS) is a 21-item questionnaire that assesses the impact of fatigue on physical, cognitive, and psychosocial functioning. Each item is rated on a 5-point Likert scale (0 = never to 4 = almost always), with a total score ranging from 0 to 84. Higher scores indicate a greater negative impact of fatigue on daily life, while lower scores suggest minimal interference with functioning. |
| Changes in fatigue severity | Baseline to Week 11 (4 weeks post-intervention) | The Fatigue Severity Scale (FSS) is a 9-item questionnaire designed to assess the impact of fatigue on daily life and functioning. Each item is rated on a 7-point Likert scale (1 = strongly disagree to 7 = strongly agree), with total scores ranging from 9 to 63. Higher scores indicate greater fatigue severity and its interference with daily activities, while lower scores suggest minimal fatigue impact. |
| Change in physical activity: Step Count | Baseline to Week 11 (4 weeks post-intervention) | The investigators will collect data on physical activity as a surrogate measure of increase in energy. The ActiGraph wGT3X-BT® is a validated accelerometer used to measure physical activity outcomes, including step count. The ActiGraph wGT3X-BT will be worn on the wrist for 5 days to yield three 24 hour data for a mean number of steps taken daily. |
| Change in Physical Activity: Energy Expenditure | Baseline to Week 11 (4 weeks post-intervention) | The investigators will collect data on physical activity as a surrogate measure of increase in energy. The ActiGraph wGT3X-BT® is a validated accelerometer used to measure physical activity outcomes, including energy expenditure. The ActiGraph wGT3X-BT will be worn on the wrist for 5 days to yield three 24 hour data for a mean energy expenditure daily. |
| Change in physical activity: Intensity of Activity | Baseline to Week 11 (4 weeks post-intervention) | The investigators will collect data on physical activity as a surrogate measure of increase in energy. The ActiGraph wGT3X-BT® is a validated accelerometer used to measure physical activity outcomes, including percentage of time spent in sedentary, light, moderate, and vigorous physical activity. The ActiGraph wGT3X-BT will be worn on the wrist for 5 days to yield three 24 hour data for a percentage of time spent in different intensity activity daily. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKetki Raina, PhD, OTR/L, FAOTA
University of Pittsburgh
Outcome results
None listed