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

Trial Summary

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 data supports the effectiveness of the 8-Week Telehealth-based Occupational Therapy Program, Self-Determination Theory-informed Occupational Therapy Program for breast cancer survivors?

Research shows that occupational therapy, including telehealth and self-determination approaches, can help improve participation in meaningful activities and enhance motivation by meeting psychological needs like autonomy and competence. While not specifically validated for breast cancer, these methods have been effective in other conditions and settings, suggesting potential benefits for breast cancer survivors. ^{1 2 3 4 5}

Is occupational therapy safe for breast cancer survivors?

The available research does not provide specific safety data for occupational therapy in breast cancer survivors, but occupational therapy is generally considered safe and beneficial for improving quality of life and well-being in various conditions. ^{1 2 6 7 8}

How is the 8-Week Telehealth-based Occupational Therapy Program different from other treatments for breast cancer survivors?

This treatment is unique because it uses telehealth to deliver occupational therapy, focusing on self-determination and client-centered approaches to help breast cancer survivors improve their daily activities and return to work. Unlike traditional in-person therapy, it offers the convenience of remote access, which can enhance accessibility and continuity of care. ^{1 4 6 8 9}

What is the purpose of this trial?

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.

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

Eligibility Criteria

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 provide informed consent

Ability to speak/read English

Owning a smartphone and/or computer with internet access

Exclusion Criteria

I am currently receiving chemotherapy or radiation as my main cancer treatment.

I am scheduled for surgery as my main treatment or for reconstruction in the next 3 months.

I am not currently in any physical or occupational therapy studies.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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 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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

A conceptual-practice model for occupational therapy to facilitate return to work in breast cancer patients. [2021]

2. Australia pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

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

4. Netherlands pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

Long-Term Impact of Model of Human Occupation Training on Therapeutic Reasoning. [2020]

6. England 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. [2016]

7. England pubmed.ncbi.nlm.nih.gov

Self-determination and older people--a concept analysis. [2014]

8. United States pubmed.ncbi.nlm.nih.gov

Telehealth Utilization Among Occupational Therapists in Oncology: Results From a National Survey. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Information and Communications Technology-Based Telehealth Approach for Occupational Therapy Interventions for Cancer Survivors: A Systematic Review. [2020]