Clinical trial NCT06654258: Supporting Spiritual Wellbeing in Young Adults With Cancer Using a Digital Health Approach: A Feasibility Study
Official title: Supporting Spiritual Wellbeing in Young Adults With Cancer Using a Digital Health Approach: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cancer
Young Adult Cancer
Keywords: spirituality
digital health
young adults
spiritual wellbeing
psychosocial wellbeing
young adult cancer
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2024-10-23
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: On average, approximately 80,000 young adults (YAs) aged 18 to 39 are diagnosed with cancer each year in the USA, accounting for approximately 5% of all cancer diagnoses. YAs experience difficulties in dealing with the physical and psychological changes associated with cancer and its treatments, the management of acute and ongoing symptoms, and worrying about progression or recurrence. In addition, YAs are also engaging in normal developmental processes across various social, emotional, and financial domains. When diagnosed with cancer, these developmental processes are disrupted, resulting in elevated psychological and psychosocial distress. Although the reported quality and severity of these impacts are largely qualitative in nature, some reports indicate that YAs diagnosed with cancer are 57% more likely to develop depression and 29% more likely to develop anxiety than YAs without cancer and are more likely to have clinically significant levels of psychological distress compared to pediatric and older adults with cancer. To ensure the needs of this population are being met, it is important that supportive interventions for YAs with cancer are acceptable and age appropriate.

Spirituality refers to an individual's search for meaning in life and personal connectedness with the divine and transcendence beyond self, other individuals, and the environment and is recognized as an essential element of person-centered care. During developmental years, it is natural for YAs to explore spirituality to inform decisions, self-understanding, and meaning-making processes, and recent survey data from a nationally representative sample indicates that \>50% of YAs report spirituality as important to them. Research has revealed that higher levels of spirituality predict better health-related quality of life in patients with cancer, even after accounting for physical and emotional wellbeing, and better patient reported mental health. However, there has been limited research exploring the unique spiritual perspectives of YAs resulting in insufficient guidance on how to best support them within this domain. Given the potential for spirituality to improve mental and physical health and to help reduce the psychosocial burden of a cancer diagnosis, research exploring spiritual self-care interventions in YAs with cancer is warranted.

Cancer patients report that they receive less spiritual care than desired from their healthcare providers. Research exploring barriers to delivering spiritual care at the bedside include time constraints, lack of confidence in effectiveness, and role uncertainty. When it comes to accessing spiritual care that is available, there are additional barriers for patients including: 1) requiring personal resources to access (e.g., transportation, time, insurance), or 2) limited options for remote, on-demand interventions despite preferences for them. Overall, there is a need and demand for accessible spiritual self-care for YAs, and addressing this gap could result in additional positive impacts on several aspects of physical and psychosocial wellbeing.

Digital health tools (e.g., smartphone apps) provide an opportunity to overcome barriers relevant to YAs with cancer including geographic mobility, time constraints, competing priorities, and limited psychosocial support providers. Furthermore, as 'digital natives', YAs are already high utilizers of technology, reducing the barrier of digital literacy in the uptake of such tools. Given the increasing focus on providing personalized, inclusive, and accessible care, leveraging digital health tools such as mobile apps may help fill the gap in addressing the unique spiritual needs of YAs with cancer and provide opportunities for efficacious, scalable interventions to increase access and reach to YAs who are most in need. Currently, research on interventions (digital or otherwise) to support spiritual wellbeing in YAs with cancer is exceedingly rare. This feasibility work will be a first step in testing whether a spiritual self-care mobile app can be used to support spiritual wellbeing in YAs with cancer.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Acceptability of spiritual self-care smartphone app
timeFrame: Week 6
measure: Demand of spiritual self-care smartphone app
timeFrame: Week 10
Secondary outcomes:
measure: Expectancy ratings of spiritual self-care smartphone app
timeFrame: Baseline
measure: Spiritual Wellbeing Scores
timeFrame: Baseline, Week 6, and Week 10 (follow-up)
measure: Life Satisfaction Scores
timeFrame: Baseline, Week 6, and Week 10 (follow-up)
measure: Positive Affect Scores
timeFrame: Baseline, Week 6, and Week 10 (follow-up)
measure: Self-Efficacy Scores
timeFrame: Baseline, Week 6, and Week 10 (follow-up)
measure: Health-Related Quality of Life Scores
timeFrame: Baseline, Week 6, and Week 10 (follow-up)
measure: Qualitative Interviews
timeFrame: Week 6
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest University Health Sciences
name: John M Salsman, PhD
role: PRINCIPAL_INVESTIGATOR
References: