Supporting Spiritual Wellbeing in Young Adults With Cancer Using a Digital Health Approach: A Feasibility Study

NCT06654258 | Withdrawn

• 1 other identifier: IRB00114969
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this research study is to collect information on how young adults (aged 18-39) receiving treatment for cancer use and rate the acceptability of a spiritual self-care smartphone app over a 6-week period. This study will test whether there may be any immediate or lasting benefits to spiritual or psychological wellbeing after using the app for 6-weeks. Collecting this information about the spiritual self-care app from young adults receiving treatment for cancer to better understand whether further testing of this smartphone app for supporting spiritual wellbeing during cancer treatment should be considered.

Conditions

Cancer; Young Adult Cancer

Keywords

spirituality; digital health; young adults; spiritual wellbeing; psychosocial wellbeing; young adult cancer

Outcome Measures

Primary Outcomes (2)

• Acceptability of spiritual self-care smartphone app

  At the end of each week of the 6-week intervention, participants will complete a brief survey to self-report: a) acceptability of the app (i.e., how enjoyable, beneficial, difficult, were your interactions with the content measured on scale of 0%-not at all to 100%-very much), b) preferred time of day, c) preferred content, d) intentions to continue use, and e) barriers and facilitators to use during the past week. At the end of the intervention period, we will assess overall acceptability of the app (i.e., how enjoyable, beneficial, difficult, etc. was the intervention overall measured on scale of 0%-not at all to 100%-very much; how likely are you to recommend this to a friend/someone with cancer).

  Week 6

• Demand of spiritual self-care smartphone app

  Study accrual and retention rates (i.e., number of participants screened, enrolled, and withdrawn throughout the study) and user statistics of app use during the 6-week study period (i.e., total number of minutes of app use per day, count of sessions per day, total days of app use).

  Week 10

Secondary Outcomes (7)

• Expectancy ratings of spiritual self-care smartphone app

  Baseline

• Spiritual Wellbeing Scores

  Baseline, Week 6, and Week 10 (follow-up)

• Life Satisfaction Scores

  Baseline, Week 6, and Week 10 (follow-up)

• Positive Affect Scores

  Baseline, Week 6, and Week 10 (follow-up)

• Self-Efficacy Scores

  Baseline, Week 6, and Week 10 (follow-up)

Study Arms (1)

Spiritual Self-Care App

EXPERIMENTAL

Smartphone app

Behavioral: Spiritual Self-Care Smartphone App

Interventions

Spiritual Self-Care Smartphone App BEHAVIORAL

Participants will be asked to engage with a commercially available spiritual self-care smartphone app on a daily basis for 6 weeks. The content spans several domains, including meditation, prayer, affirmations, movement (i.e., stretching and yoga), and music. The user experience is highly personalized, allowing the user to select content that matches their current: mood or needs (e.g., anxiety, loneliness, stress, self-esteem, and sleep), time of day (e.g., recommendations for morning and evening practices), and/or availability (e.g., very brief "micro-interventions" lasting no more than 90 seconds or longer activities up to 30 minutes in duration). The content is delivered via a combination of audio and visual modalities on a personal smartphone that can be toggled on and off to adjust to surroundings.

Spiritual Self-Care App

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Young adults between the ages of 18 and 39
• Histologically confirmed diagnosis of cancer (except basal cell skin carcinoma)
• For patients with solid tumors, patients must be within 12-weeks of current cancer diagnosis upon enrollment and currently receiving curative treatment (i.e., surgery and/or chemotherapy and/or radiation therapy; surgery-only patients must be within 6-weeks of surgery at time of enrollment). For patients with hematological cancers, there is no requirement for time since diagnosis, provided they are receiving treatment, including stable maintenance management.
• Able to provide informed consent and fluent in English for completion of study questionnaires
• Residing in the USA
• Internet access
• Own a smartphone with an active data plan or wi-fi
• Have a personal email address

You may not qualify if:

• Unable to provide informed consent
• Not currently engaging in curative cancer treatment(s) (i.e., awaiting treatment initiation, completed curative treatment(s))
• Currently receiving end-of-life palliative care or hospice care

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

MeSH Terms

Conditions

Neoplasms

Study Officials

• John M Salsman, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 23, 2024
• Study Start: October 1, 2024
• Primary Completion: November 21, 2024
• Study Completion: November 21, 2024
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share