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Behavioural Intervention

Occupational Therapy for Breast Cancer Survivors (SDOTS Trial)

N/A

Recruiting

Led By Zachary C Pope, PhD

Research Sponsored by University of Oklahoma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥18 years old

Having ever received a histologically confirmed diagnosis of invasive breast carcinoma

Must not have

Currently undergoing chemotherapy or radiation as primary cancer treatment

Presence of distant metastasis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to test a new 8-week occupational therapy program for breast cancer survivors. The program will be delivered through telehealth to make it easier for survivors, especially those in rural areas like Oklahoma

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the intervention involves exercise, potential side effects may include typical exercise-related discomforts such as muscle soreness, fatigue, or strain injuries. However, these are generally mild and manageable.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been diagnosed with invasive breast cancer.

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I had surgery for breast cancer within the last year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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My cancer has spread to distant parts of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during the baseline week and study week 9

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during the baseline week and study week 9

This trial's timeline: 3 weeks for screening, Varies for treatment, and during the baseline week and study week 9 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Program Acceptability

Program Usability

Program Usefulness

Secondary study objectives

Feasibility: Program Adherence

Feasibility: Program Recruitment

Feasibility: Program Retention

+1 more

Other study objectives

Goal Attainment

Health-related Quality of Life

MSE Bouts

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: 8-Week Telehealth-delivered Occupational Therapy ProgramExperimental Treatment1 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).

0 / 5Eligibility criteria met