Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

Source: NCT06671730

Recruiting

SDOTS: Self-Determination Theory-informed Occupational Therapy Program to Increase Physical Activity Among Survivors of Breast Cancer

Interventional

Phase not listed

University of Oklahoma Health Sciences

We will evaluate a novel 8-week telehealth-delivered occupational therapy (OT) program among breast cancer survivors that seeks to promote engagement in aerobic physical activity (PA) and muscle strengthening exercise (MSE). The telehealth-based delivery of this OT program circumvents some barriers to OT access and participation (e.g., time burden; distance to OT clinic) among breast cancer survivors- particularly important for Oklahoma given that 33% of residents live in rural areas. Additionally, the focus of this program is to promote the preferred aerobic PA and MSE choices of each individual survivor to increase the likelihood of long-term PA engagement. In turn, participants will be more likely to experience the longer-term benefits associated with PA such as improved physical functioning, reduced anxiety, depressive, and pain symptoms, better sleep, and better cardiorespiratory fitness.

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Treatment Category

Behavioral

Required Mutations

None

Trial Started

2024-11-27

Last Updated by Sponsor

2025-03-25

Estimated Completion

2025-07-31

Eligibility

Inclusion Criteria

1. ≥18 years old.

2. Ability to speak/read English.

3. Ability to provide informed consent.

4. Having ever received a histologically confirmed diagnosis of invasive breast carcinoma.

5. Having undergone breast conserving surgery or mastectomy for BC in the last 12 months.

6. Owning a smartphone and/or computer with internet access.

7. Willing to participate in once-weekly telehealth-delivered OT sessions for eight weeks.

Exclusion Criteria

1. Currently undergoing chemotherapy or radiation as primary cancer treatment.

2. Planning or preparing for surgery as primary treatment or as a reconstruction procedure in the next 3 months.

3. Presence of distant metastasis.

4. Reporting a Physical Activity Readiness Questionnaire (2017 PAR-Q+) score that indicates PA may potentially be unsafe, unless the participant produces a signed doctor's note. We will define 2017 PAR-Q+ scores as indicating that PA may potentially be unsafe as responding "Yes" to any of the follow-up questions except [1] if the individual indicates that they have high blood pressure but subsequent responses indicate that both they do not have problems keeping it under control and that their resting blood pressure is less than 160/90 mmHg, and [2] if the individual indicates that they have a metabolic condition but subsequent responses indicate that they do not have problems controlling their blood sugar levels, do not any experience signs or symptoms of hypoglycemia, and do not have any signs of symptoms of listed diabetes complications).

5. Already engaging in ≥ 75 min/week of vigorous-intensity PA, ≥ 150 min/week of moderate-intensity PA, or an equivalent combination of both over the last 3 months.

6. Being a prisoner, pregnant, or planning to become pregnant.

7. Currently participating in another PA- or OT-based study, or seeking physical therapy or occupational therapy treatment.

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Design Details

AllocationN/A

Intervention ModelSingle Group Assignment

MaskingNone (Open Label)

Number to Enroll38

Arms & Interventions

Arms

Interventions

Type: Experimental

Description: The telehealth-based OT program will be grounded in SDT. The program will be designed to help BC survivors transition from recovery after surgery to achieving levels of aerobic PA and MSE that are recommended according to each participants' specific treatment course and desired outcomes. Participants will engage in eight once-weekly OT sessions with a licensed occupational therapist via Zoom-lasting for up to about an hour. Each session will teach psychoeducational and skill-building techniques that support decreasing functional limitations associated with BC and BC treatment as well as improving behavioral skill sets necessary for maintenance of aerobic PA and MSE. Participants will receive study-provided exercise equipment and a fitness tracker (Fitbit Charge 6) for use engaging in greater amounts of aerobic PA and MSE (keeping these materials post-study).

Interventions:

8-Week Telehealth-based Occupational Therapy Program

Outcome Measures

Primary Outcome Measures

Program AcceptabilityEnd of Study Week 8

Semi-structured Interviews and face valid questionnaires will be used to determine whether BC survivors found the intervention acceptable. The semi-structured interviews will be evaluated via thematic analysis, and the questionnaires will be scored on a 7-point Likert scale (1: 'Not at all'; 7: 'Very'), with higher scores being better.

Program UsabilityEnd of Study Week 8

Semi-structured interviews and face valid questionnaires will be used to determine whether BC survivors found the intervention useful as well as how it could be improved in the future. The semi-structured interviews will be evaluated via thematic analysis, and the questionnaires will be scored on a 7-point Likert scale (1: 'Not at all'; 7: 'Very'), with higher scores being better.

Program UsefulnessEnd of Study Week 8

Semi-structured Interviews and face valid questionnaires will be used to determine whether BC survivors found the intervention useful at helping them increase their ability to engage in PAs that they value most. The semi-structured interviews will be evaluated via thematic analysis, and the questionnaires will be scored on a 7-point Likert scale (1: 'Not at all'; 7: 'Very'), with higher scores being better.

Secondary Outcome Measures

Feasibility: Program RecruitmentFrom Baseline through Study Week 8

Recruitment rates will be reported as the proportion of BC survivors enrolled in the study divided by the number of BC survivors who complete the screening survey. Enrollment will be considered feasible if ≥70% of eligible and approached BC survivors consent and enroll.

Feasibility: Program RetentionFrom Baseline through Study Week 8

Study retention will be the number of BC survivors completing the program divided by the number that started. Retention will be considered feasible if ≥80% BC survivors who complete the baseline measures also complete measures post-program.

Feasibility: Program AdherenceFrom Baseline through Study Week 8

The number of weekly telehealth-delivered OT sessions (out of eight total sessions) that each participant attends will be used as the program adherence metric. Adherence will be considered feasible if participants average ≥80% attendance OT sessions.

Program Safety: Incidence of Lymphedema Events, Musculoskeletal Injuries, and Adverse EventsFrom Baseline through Study Week 8

Assessments of program safety will be assessed by tracking any BC-related lymphedema events, musculoskeletal injuries, and adverse events. The occupational therapist will track this information each week during each participant's telehealth-delivered OT session. The program will be considered safe if these events occur at or below published normative values.

Psychological Needs SatisfactionFrom Baseline through Study Week 8

We will assess participants' pre- to post-program changes in SDT constructs through examinations of basic psychological needs satisfaction in exercise. We will operationalize these constructs using the Basic Psychological Needs in Exercise Scale. This 11-item Likert-type scale that features three subscales that measure perceptions of autonomy, competence, and relatedness (1: "I don't agree at all"; 5: "I completely agree").

Theory Intervention Fidelity TestEnd of Study Week 8

This measure will allow us to assess participants' perceptions of having experienced the SDT's underlying mechanisms of behavior change (autonomy, competence, and relatedness) as well as meaning associated with the intervention's aim (i.e., to increase engagement in personally meaningful physical activities). Responses are on a 7-point Likert-type scale (1: "Strongly disagree"; 7: "Strongly agree"), with higher scores better.

Supportive Accountability InventoryEnd of Study Week 8

The Supportive Accountability Inventory will allow us to assess the degree of supportive accountability participants felt the study occupational therapist provided during the course of the program. Participants will respond on a 7-point Likert scale (1 = 'Strongly disagree; 7 = 'Strongly agree').

Physical ActivityDuring the Baseline Week and Study Week 9

Measurements of pre- to post-program changes in aerobic PA will be completed using ActiGraph GT3X accelerometers. Durations of moderate-vigorous physical activity [MVPA], light physical activity [LPA], and sedentary behavior (SB) reported will aggregated and reported as our single overall physical activity metric.

MSE BoutsFrom Baseline through Study Week 8

Pre- to post-program changes in weekly MSE bouts will be tracked as the occupational therapist discusses PA goals with each participant during their once-weekly OT session. The occupational therapist's notes will be used to determine the percentage of program weeks that BC survivors meet the recommended two bouts of MSE per week.

Health-related Quality of LifeBaseline and End of Study Week 8

We will evaluate pre- to post-program changes in HRQoL using patient-reported outcomes. We will assess the following eight components of physical and psychological health at baseline and post-program using the Patient-Reported Outcomes Measurement Information System (PROMIS): physical functioning, fatigue, anxiety, depression, pain interference, pain intensity, sleep impairment, and sleep disturbance. Measurements on the PROMIS are on a 5-point Likert-type scale, with 5 reflecting worse outcomes on all components aside from physical function wherein a higher score reflects better physical function. These PROMIS measures have been observed as reliable tools for the assessment of these outcomes.

Goal AttainmentFrom Baseline through Study Week 8

We will measure Goal attainment via goal attainment scaling (GAS). Measurement/Analysis: GAS allows for reporting the extent to which a participant meets weekly goals using a 5-point scale (-2 [minimum]: performance was much worse than expected; +2 [maximum]: performance was much better than expected). Measurement of pre-post changes obtained through transforming into a single aggregate score using established protocols.

Sociodemographics and Health HistoryBaseline

We will collect social and demographic variables at baseline to ensure we can best describe our sample and explain observation nuances (e.g., age, sex, race/ethnicity, education, height and weight, marital status, annual household income, date of BC diagnosis and stage at diagnosis, type of BC treatment(s) received, comorbidities [e.g., type II diabetes], readiness to change, and overall health status).