A Trial for a Preliminary Estimate of the Effectiveness of a Novel Theoretical Framework

NCT06461416 | Completed

• 1 other identifier: 276865
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

• Aim 1: To determine the preliminary effect sizes of al ActiveHeal EST (Engage-Sustain-Triumph) Program on occupational resilience.
• Aim 2: To determine the preliminary effect sizes of ActiveHeal EST (Engage-Sustain-Triumph) on health status \[quality of life (QoL) and Psychological wellbeing (PWB)\].
• Aim 3: To determine the extent to which ActiveHeal EST (Engage-Sustain-Triumph) Program is an acceptable and feasible Intervention for breast and prostate cancer survivors.

Conditions

Prostate Cancer; Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Occupational Resilience Measure (ORM 1.0)

  The ability to persist in selected daily activity despite challenges

  Week 7-8; Week 22-23

Secondary Outcomes (2)

• World Health Organization Quality of Life Scale (WHOQOL-BREF)

  Week 7-8; Week 22-23

• Psychological Wellbeing Scale

  Week 7-8; Week 22-23

Other Outcomes (2)

• Acceptability of Intervention Measure- Experiment Group only

  Week 22-23

• Feasibility of Intervention Measure- Experiment Group only

  Week 22-23

Study Arms (2)

Intervention

EXPERIMENTAL

Group A will receive telehealth occupational therapy services for 12 weeks

Behavioral: ActiveHeal

Control

NO INTERVENTION

Group B will meet three times via zoom but not receive an intervention

Interventions

ActiveHeal BEHAVIORAL

Participants will have 6 group activity sessions and six individualized sessions from home, all focused on optimizing persistence in performance of specific selected activities.

Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be an adult, diagnosed within the last 12 months with prostate or breast cancer and have had treatment(s) that may be ongoing or completed.
• Must be 18-75 years old.

You may not qualify if:

• Unable to use or lacking access to Teams (internet) and telephone during the study period.
• Unable or unwilling to participate in activity-based interventions.

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Science

Fayetteville, Arkansas, 72203, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will utilize the randomized study design with two groups of 15 participants in each arm. The intervention group will receive telehealth occupational therapy services for 12 weeks. The control group will meet three times via zoom but not receive an intervention. All participants will have three assessments completed before and after the intervention.

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 17, 2024
• Study Start: June 10, 2024
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: September 10, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)