Occupational Therapy for Breast Cancer Survivors

(SDOTS Trial)

Overseen By Tara C Klinedinst, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Oklahoma

Disqualifiers: Chemotherapy, Radiation, Metastasis, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks

38 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new online occupational therapy program designed to help breast cancer survivors become more active. The program aims to simplify aerobic exercises and muscle-strengthening activities at home, potentially improving physical health and mood over time. It is ideal for individuals who underwent breast cancer surgery in the past year, have internet access, and are interested in weekly online sessions. Participants will receive exercise equipment and a fitness tracker to support their activity. As an unphased trial, this study provides participants the chance to contribute to innovative research that could enhance recovery and quality of life for breast cancer survivors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It mainly focuses on your physical activity levels and current cancer treatments.

What prior data suggests that this telehealth-based occupational therapy program is safe for breast cancer survivors?

Previous studies have shown that telehealth-delivered occupational therapy is safe and easy to manage. This therapy helps individuals resume normal activities after treatment without clinic visits. Participants in similar programs reported positive experiences with few side effects. The therapy involves weekly sessions with a therapist and carries no known serious risks. This makes it a promising option for improving physical activity and overall well-being after breast cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the 8-week telehealth-based occupational therapy program for breast cancer survivors because it offers a personalized, convenient approach to recovery. Unlike traditional in-person therapies, this program is delivered via Zoom, making it accessible for those who may have mobility issues or busy schedules. It focuses on helping survivors transition from surgery recovery to recommended levels of physical activity by teaching psychoeducational and skill-building techniques. Additionally, participants receive exercise equipment and a Fitbit, which encourages ongoing engagement and self-monitoring of their progress. This approach combines modern technology with tailored therapy, potentially enhancing long-term health outcomes for breast cancer survivors.

What evidence suggests that this telehealth-based occupational therapy program is effective for breast cancer survivors?

Research has shown that occupational therapy (OT) can help breast cancer survivors become more active and improve overall well-being. Studies have found that regular aerobic exercises and strength training enhance physical abilities and reduce anxiety, depression, and pain. This trial will evaluate an 8-Week Telehealth-based Occupational Therapy Program. Early results suggest it can be effective, as it allows patients to receive therapy at home. This method helps survivors maintain long-term physical activity, which is linked to better sleep and improved heart and lung health. The program is based on Self-Determination Theory, which helps participants stay motivated and focused on their health goals. ^{2 3 4 5 6}

Who Is on the Research Team?

Tara C Klinedinst, PhD

Principal Investigator

University of Oklahoma Health Sciences

Michael C Robertson, PhD, MPH

Principal Investigator

University of Oklahoma Health Sciences

Zachary C Pope, PhD

Principal Investigator

University of Oklahoma Health Sciences

Are You a Good Fit for This Trial?

This trial is for breast cancer survivors who could benefit from increased physical activity. It's an 8-week program delivered via telehealth, making it accessible especially to those in rural areas or with time constraints. Participants should be interested in aerobic and muscle-strengthening exercises.

Inclusion Criteria

Ability to speak/read English

Ability to provide informed consent

Owning a smartphone and/or computer with internet access

Exclusion Criteria

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

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

Being a prisoner, pregnant, or planning to become pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in an 8-week telehealth-delivered occupational therapy program focusing on aerobic physical activity and muscle strengthening exercises.

8 weeks

8 weekly telehealth sessions

Follow-up

Participants are monitored for safety and effectiveness after the treatment program, including assessments of physical activity and health-related quality of life.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 8-Week Telehealth-based Occupational Therapy Program

Trial Overview The intervention being tested is a telehealth-based occupational therapy program designed to encourage breast cancer survivors to engage more in physical activities like aerobic exercises and muscle strengthening over eight weeks.

How Is the Trial Designed?

Group I: 8-Week Telehealth-delivered Occupational Therapy Program Experimental Treatment 1 Intervention

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).

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

Published Research Related to This Trial

Occupational therapists who received Model of Human Occupation (MOHO) training reported significant long-term benefits, retaining knowledge and implementing practice changes 9 months after training, which enhanced their client-centered approach in cancer rehabilitation.

The study suggests that MOHO training not only improves therapists' understanding of the model but also positively influences their therapeutic reasoning and practice, indicating a need for further research on its impact in different settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Impact of Model of Human Occupation Training on Therapeutic Reasoning. Bowyer, P., Munoz, L., Tkach, MM., et al.[2020]

The study defined self-determination for community-dwelling frail older people as a process where individuals have control, legal/ethical rights, and the ability to make their own decisions, emphasizing its importance in rehabilitation and occupational therapy.

Through analyzing 21 articles, the research highlighted that self-determination encompasses various contexts, including everyday decision-making and the perspectives of professionals, which can vary across different cultural settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-determination and older people--a concept analysis. Ekelund, C., Dahlin-Ivanoff, S., Eklund, K.[2014]

A 5-week occupational therapy program called Take Action helped a 56-year-old breast cancer survivor improve her cognitive function and daily activities after chemotherapy, emphasizing the importance of personalized interventions.

The program focused on enhancing the survivor's sense of self and occupational performance, demonstrating the critical role of occupational therapists in supporting cancer survivors' reintegration into daily life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Re-defining one's occupational self 2 years after breast cancer: a case study. Newman, RM.[2013]

Occupational therapy (OT) can play a crucial role in helping breast cancer patients return to work by providing tailored rehabilitation that addresses their specific needs, as identified through interviews with experts in the field.

Experts emphasize the importance of integrating OT interventions early in the rehabilitation process and within multidisciplinary teams, but highlight that organizational barriers, such as lack of insurance reimbursement, need to be addressed to make these services accessible.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is the value of occupational therapy in return to work for breast cancer patients? A qualitative inquiry among experts. Désiron, HA., Donceel, P., Godderis, L., et al.[2016]

Occupational therapy (OT) interventions have not yet been validated for assisting breast cancer patients in returning to work (RTW), highlighting a significant gap in support for this population.

The Model of Human Occupation (MOHO) was identified as the most suitable OT model for adapting to the needs of breast cancer patients, suggesting that with modifications, it could effectively address their individual and societal needs during the RTW process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A conceptual-practice model for occupational therapy to facilitate return to work in breast cancer patients. Désiron, HA., Donceel, P., de Rijk, A., et al.[2021]

A study of 126 occupational therapy practitioners revealed that most support the use of telehealth in oncology, particularly valuing its accessibility, which was endorsed by 48% of respondents.

Telehealth is seen as beneficial for delivering occupational therapy treatments, especially in areas like education (41%), quality of life (21%), and psychosocial interventions (19%), highlighting the need for continued advocacy for telehealth access and reimbursement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth Utilization Among Occupational Therapists in Oncology: Results From a National Survey. Sleight, AG., Klein, CM., Feldman, AE., et al.[2023]

Telehealth (TH) approaches in occupational therapy (OT) have been shown to positively impact physical and cognitive functions, as well as reduce cancer-related symptoms like pain and fatigue in adult cancer survivors, based on a review of 15 studies.

While the review highlighted the effectiveness of various TH interventions, it noted a lack of direct evidence linking these interventions to improved occupational engagement, suggesting a need for further OT-specific research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Information and Communications Technology-Based Telehealth Approach for Occupational Therapy Interventions for Cancer Survivors: A Systematic Review. Hwang, NK., Jung, YJ., Park, JS.[2020]

The World Federation of Occupational Therapists supports the use of telehealth for delivering occupational therapy services, allowing practitioners to evaluate and intervene with clients remotely using information and communication technologies.

Telehealth services must be tailored to the needs and cultural contexts of clients, and practitioners should consider various factors such as licensure, collaboration with local therapists, and professional standards to ensure effective and safe practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

World Federation of occupational therapists' position statement on telehealth. [2022]

Self-determination is crucial in occupational therapy, as it emphasizes individual choice and control, aligning with Australia's National Disability Insurance Scheme to enhance client wellbeing.

Utilizing Self-Determination Theory (SDT) in practice can improve therapy outcomes by addressing clients' psychological needs for autonomy, relatedness, and competence, fostering a stronger therapeutic alliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occupational performance: a case for self-determination. Ziviani, J.[2016]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06671730

Self-Determination Theory-informed Occupational Therapy ... We will evaluate a novel 8-week telehealth-delivered occupational therapy (OT) program among breast cancer survivors that seeks to promote engagement in ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12514410/

Digitally Mediated Occupational Therapy to Increase ... The program is designed to help breast cancer survivors transition from recovery after surgery to achieving levels of aerobic PA and MSE that ...

3. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/552216

Self-Determination Theory-informed Occupational Therapy ... We will evaluate a novel 8-week telehealth-delivered occupational therapy (OT) program among breast cancer survivors that seeks to promote ...

4. withpower.com withpower.com/trial/phase-breast-neoplasms-10-2024-cc0a8

Occupational Therapy for Breast Cancer Survivors We will evaluate a novel 8-week telehealth-delivered occupational therapy (OT) program among breast cancer survivors that seeks to promote engagement in ...

5. ancora.ai ancora.ai/de/details/NCT06671730

Self-Determination Theory-informed Occupational Therapy ... We will evaluate a novel 8-week telehealth-delivered occupational therapy (OT) program among breast cancer survivors that seeks to promote engagement in ae.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06671730

Self-Determination Theory-informed Occupational Therapy ... We will evaluate a novel 8-week telehealth-delivered occupational therapy (OT) program among breast cancer survivors that seeks to promote engagement in ...