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

Breast Cancer Clinical Trial

Official title: Occupational Resilience: A Pilot Trial for a Preliminary Estimate of the Effectiveness of a Novel Theoretical Framework

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

The study will utilize the randomized study design with two groups of 20 participants each arm. The intervention group will receive 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. The experimental group will have a feasibility and acceptability survey at the end of the intervention.

Week 1-6 Recruitment, Informed Consent Process Commenced, and Randomization (Both Groups A & B) Week 7-8 Pretests: Administer Occupational Resilience Measure (ORM 1.0), World Health Organization Quality of Life Scale (WHOQOL BREF), and Psychological Wellbeing Scale. To be completed with participant via Zoom (Both Groups A & B) Week 9, 11,13, 15, 17 &19 (Week 1, 3, 5, 7, 9 & 11 of the ActiveHeal EST (Engage-Sustain-Triumph)Program) Six Group ActiveHeal EST Sessions (Group A only). Each session is 75 minutes. It will include education on benefits of activity and strategies to make sustained performance possible, highlighting History, Experience, Benefits, and Adaptation (Location: UAMS Northwest Campus). The group sessions will be led by the PI (or one of the trained occupational therapists who are familiar with the applied group and individual therapy process) and a student assistant to assist in the specified group activity performance. Although the intervention approach is specific, the use of activity as intervention is well understood by any certified occupational therapist. The training will therefore focus on what the sessions look like if these four factors are the guide to group or individual intervention. Four additional therapists will be trained by PI in a 60 minute group session, to be able lead individual or group sessions.

ActiveHeal EST (Engage-Sustain-Triumph) group sessions will utilize a developmental group intervention model. Such intervention models allow the group to increasingly take charge of group activities and processes, with more structure and support at the beginning but members gradually take over leadership and group management roles, ideally running the group and meeting shared goals without a therapist by the end of the process . This model is selected because it has potential to enable members to develop relationships and build capacities that allow them to support one another after the intervention period. The model is also selected to allow participants to draw from benefits of group interventions, including installation of hope, universality, imparting of knowledge, altruism, corrective family re-enactment, development of socialization skills, imitative behavior, interpersonal learning, group cohesiveness, catharsis, and finding meaning.

Because these models are known to be optimal with 5-10 participants, Group A participants will be divided into two groups, but the same session plan will be used on the day of the meetings. That is, there will be two similar sessions per day of meeting, and participants will attend one session, with the same group each time. Group members will vote for their preferred activities for the upcoming meeting and the activities that are favored by the majority will be selected if consistent with group goals. These activities may include group physical exercise, healthy meal preparation activity, meditation, yoga, guided imagery, music experience (listening and/or performance) and dance.

All ActiveHeal EST (Engage-Sustain-Triumph) sessions will follow Cole's 7 steps, which are:

Introduction, Activity, Sharing, Processing, Generalizing, Application, and Summary. These 7 steps will allow participants contemplate and share their experiences with a particular activity [History], demonstrate or build capacity for activity performance [Experience], reflect on health benefits of an activity [Benefits] and consider ways to sustain activity when barriers emerge []adaptation]. The 7 steps ensure that in each session group members will 1) undertake an activity as a group, 2) reflect or share how they have or could apply this activity to support health, and 3) develop a feasible plan for its application while keeping in mind possible barriers and potential solutions to optimize activity engagement.

Each ActiveHeal EST (Engage-Sustain-Triumph) session will include a blend of 1) educational content and 2) an activity for each session used to facilitate learning. Tentatively, the session themes include:

Everyday enjoyment of music Adaptation - What if I can't do it today? Developing and sustaining habits Therapeutic use of arts and crafts Applying meditation practices Making healthy eating a habit

Session themes about content will be retained regardless of the kind of activities selected by group members, but activities will be determined in consultation with group members, consistent with commonly accepted group intervention guidelines.

Educational content will consistently highlight the impact of History, Experience, Benefits and Adaptation on long-term activity performance, and strategies for promoting success in enduring activity performance. Regardless of the activity selected, four OR factors will be covered within Cole's last 3 steps, led by an occupational therapist and an assistant.

Week 11 & 14 (Week 3 and 6 of active study period) Control Group B Meeting via Zoom - this study meeting lasts 15 to 30 minutes allowing the PI to touch base with the control participants to see how they are doing. This meeting is not intended to be therapeutic or interventional.

Week 10, 12, 14, 16, 18 & 20 (Week 2, 4, 6, 8, 10 & 12 of the ActiveHeal EST (Engage-Sustain-Triumph) Program) Six Individualized ActiveHeal EST (Engage-Sustain-Triumph) Sessions (Group A only): Each participant in the experiment group will receive 6 occupational therapy visits at their home or other selected location. This session will focus on the activities that the participants selected at the start of the program. Using the methods covered in group sessions to strengthen activity performance, with individualized occupational therapy intervention added. All interventions will focus on building History, Experience, Benefits, and Adaptation. More focus may be given to any of the four, based on a participant's strengths and weaknesses, at the discretion of treating therapist. All four factors must be addressed and documented per visit.

Week 17 (Week 9 of active study period) Control Group B Meeting via Zoom - this study meeting lasts 15 to 30 minutes allowing the PI to touch base with the control participants to see how they are doing. This meeting is not intended to be therapeutic or interventional.

Week 21-22 Posttests - (Re-administer Occupational Resilience Measure (ORM 1.0), World Health Organization Quality of Life Scale (WHOQOL BREF), and Psychological Wellbeing Scale. To be completed with participant via Zoom. (Both Groups A & B). Group A will additionally complete Acceptability of Intervention Measure (AIM) and Feasibility of Intervention Measure (FIM). ;

Related Conditions & MeSH terms

• Breast Cancer
• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT06461416
• Study type: Interventional
• Source: University of Arkansas
• Contact: Bernard AK Muriithi, PhD
• Phone: 14806651643
• Email: bmuriithi@uams.edu
• Status: Recruiting
• Phase: N/A
• Start date: June 10, 2024
• Completion date: December 30, 2024