Self-Acceptance and Supportive Accountability for Active Living Among Adults Receiving Chemotherapy

N/ACompletedNCT07819045

University of Oklahoma42 enrolled

Overview

Physical activity can improve health-related quality of life among people receiving cancer treatment. Yet, chemotherapy imposes considerable barriers to maintaining an active lifestyle. Emotion regulation-based approaches based on principles from Self-Determination Theory (SDT) and Acceptance and Commitment Therapy (ACT) may help people engage in physical activity despite treatment-related challenges. We aimed to develop and conduct a proof of concept study among people initiating chemotherapy for breast and gynecologic cancers to develop and assess the feasibility and acceptability of a novel, mobile health physical activity intervention that drew from SDT and ACT principles.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Metastatic Invasive Breast Cancer Metastatic Invasive Gynecologic Cancer

Interventions

This intervention will be delivered over the course of up to 8-12 weeks. It will include: 1) the provision of a wearable physical activity tracker 2) empirically supported behavior change techniques for promoting physical activity 3) Acceptance and Commitment Therapy-informed didactic content centered on promoting physical activity 4) a social component with game design elements reflecting acceptance and mindfulness practices (i.e., the ability to share responses to "Weekly Challenges" and view and comment on others' entries).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion criteria: * Having ever received a histologically confirmed diagnosis of invasive breast or gynecologic carcinoma (eligible cancer types include epithelial ovarian carcinoma, endometrial/uterine carcinoma, and invasive cervical carcinoma; other rare gynecologic malignancies \[e.g., vaginal, vulvar\] may also be included if explicitly approved by the study team) * Scheduled to receive cytotoxic chemotherapy for a minimum of 4 consecutive weeks but not yet begun or are within 4 weeks of having started their chemotherapy for cancer * Ability to speak and read English * Having internet access * Being willing and able to use a smartphone and web interface with or without assistance. If assistance is needed, it must be readily available * Adequate visual and hearing acuity to use a smartphone and web interface as indicated by self-report * Adequate motor capacity to use a smartphone and web interface as indicated by self-report * Willingness to download and use study-specific app(s), the Fitbit mobile application (this requires use of a Google Gmail account), and other mobile applications for study purposes Exclusion criteria: * Eastern Cooperative Oncology Group test score \> 2 * Having unstable bone metastases * Untreated brain metastases * Contraindications to physical activity (e.g., uncontrolled hypertension or cardiac disease) * Having a body mass index under 18 * Major psychiatric conditions such as bipolar disorder, psychosis, schizophrenia, or alcoholism that could affect the ability to understand and/or complete the study * Having arthritic or orthopedic issues that would preclude physical exercise * Another member of the household is a primary participant or staff member on this trial * Being a prisoner * Living in an assisted living facility or nursing home * Enrolled in hospice

Outcomes

Primary Outcomes

Semi-structured Interviews

Semi-structured interviews will be used to assess participants' overall experience and their perceptions of the usability, usefulness, and enjoyability of the intervention.

Time frame: 9 weeks

Perceived ease of use

Face valid questions will be used to determine whether participants found the interventions easy to use. The face valid questions consists of five 7-point Likert-type items. Responses range from "Not At All Easy" (scored as 1) to "Very Easy" (scored as 7). Higher scores reflect greater ease of use.

Time frame: Week 9

Perceived Usefulness

Face valid questions will be used to determine whether participants found the interventions useful. The face valid questions consists of five 7-point Likert-type items. Responses range from "Not At All Useful" (scored as 1) to "Very Useful" (scored as 7). Higher scores reflect greater perceived usefulness.

Time frame: Week 9

Enjoyability

Face valid questions will be used to assess the enjoyability of the interventions in this study. The face valid questions consists of five 7-point Likert-type items. Responses range from "Not At All Enjoyable" (scored as 1) to "Very Enjoyable" (scored as 7). Higher scores reflect greater enjoyability.

Time frame: Week 9

Enjoyability - Interest/Enjoyment Subscale

The interest/enjoyment subscale of the Intrinsic Motivation Inventory (IMIe) will be used to assess the enjoyability of the interventions in this study. The IMIe sub-scale consists of seven 7-point Likert-type items. Responses range from "Not At All True" (scored as 1) to "Very True" (scored as 7). Higher scores reflect greater enjoyability.

Time frame: Week 9

Feasibility of the Program - Study Retention

We will assess program feasibility via measurements of study retention. We will compute what percentage of enrolled participant complete post-intervention data collection procedures.

Time frame: Week 9

Feasibility of the Program - Adherence

We will assess program feasibility via measurements of intervention adherence. We will compute what percentage of participants engage with at least 75% of the intervention modules.

Time frame: Week 9

Feasibility of Collecting Biological Samples

We will assess the feasibility of assessing gene expression in the present context by assessing what percentage of enrolled participants provide analyzable data in optional post-intervention blood draws.

Time frame: Week 9

Self-Acceptance and Supportive Accountability for Active Living Among Adults Receiving Chemotherapy

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes