CancerNCT06654258
Supporting Spiritual Wellbeing in Young Adults With Cancer Using a Digital Health Approach: A Feasibility Study
A study testing Spiritual Self-Care Smartphone App in people with Cancer and Young Adult Cancer, run by Wake Forest University Health Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Cancer, Young Adult Cancer
- What is being tested?
- Spiritual Self-Care Smartphone App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 21 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
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.
Read the 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.
- Conditions
- Cancer, Young Adult Cancer
- Being tested
- Spiritual Self-Care Smartphone App
- Keywords
- spirituality, digital health, young adults, spiritual wellbeing, psychosocial wellbeing, young adult cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spiritual Self-Care Smartphone AppBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Spiritual Self-Care App | Experimental | Smartphone app Receives: Behavioral: Spiritual Self-Care Smartphone App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Week 10
Secondary outcomes (7)
Expectancy ratings of spiritual self-care smartphone app
Baseline expectancy before engaging with the app (i.e., how enjoyable, beneficial, difficult, do you think this intervention will be? measured on a scale of 0%-not at all to 100%-very much - higher score denoting higher acceptance) and confidence in intentions to use the app daily.
Measured: Baseline
Spiritual Wellbeing Scores
12-item Functional Assessment of Cancer Therapy - Spiritual Wellbeing (FACIT-Sp-12). Includes 12 items scored on a scale of 0 (not at all) to 4 (very much). A total score and 3 subscale scores (i.e., faith, meaning, peace) can be calculated with higher scores indicating greater levels of spiritual wellbeing (Scores range from 0-36)
Measured: Baseline, Week 6, and Week 10 (follow-up)
Life Satisfaction Scores
NIH Toolbox short form assessing life satisfaction. 5 items scored on a scale of 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate greater life satisfaction (Scores range from 5-35)
Measured: Baseline, Week 6, and Week 10 (follow-up)
Positive Affect Scores
NIH Toolbox short form assessing positive affect. 15 items scored on a scale of 1 (not at all) to 5 (very much). Higher scores indicate greater positive affect.
Measured: Baseline, Week 6, and Week 10 (follow-up)
Self-Efficacy Scores
PROMIS short form assessing general self-efficacy. 4 items scored on a scale of 1 (I am not at all confident) to 5 (I am very confident). Higher scores indicative of higher levels of self-efficacy.
Measured: Baseline, Week 6, and Week 10 (follow-up)
Health-Related Quality of Life Scores
PROMIS AYA Health Status Profile to capture health-related quality of life domains, including depression, anxiety, fatigue, physical function, pain interference, emotional support, and cognitive function, and pain intensity.
Measured: Baseline, Week 6, and Week 10 (follow-up)
Qualitative Interviews
A subsample of participants (~10-12) will be asked to discuss their attitudes about the app, internal and external factors that prevented them from using the app when they intended to, along with the factors that supported their use of the app.
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start1 Oct 2024
- Primary completion21 Nov 2024
- Study completion21 Nov 2024
Why it stopped: Smartphone application being tested in this study was removed from commercial use
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John M Salsman, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06654258
- Sponsor's protocol ID
- IRB00114969
- Status last verified
- Nov 2024
- First submitted
- 21 Oct 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Pilot data that is descriptive in nature
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supporting Spiritual Wellbeing in Young Adults With Cancer Using a Digital Health Approach: A Feasibility Study
- ClinicalTrials.gov ID
- NCT06654258
- Acronym / sponsor ID
- IRB00114969
- Conditions
- Cancer, Young Adult Cancer
- Keywords
- spirituality, digital health, young adults, spiritual wellbeing, psychosocial wellbeing, young adult cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Smartphone application being tested in this study was removed from commercial use
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 21 Nov 2024 (actual)
- Study completion
- 21 Nov 2024 (actual)
- First posted
- 23 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spiritual Self-Care App | Experimental | Behavioral: Spiritual Self-Care Smartphone AppSmartphone app |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spiritual Self-Care Smartphone AppParticipants 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. | Behavioural | Spiritual Self-Care App |
Primary outcome
Acceptability of spiritual self-care smartphone app
Time frame: Week 6
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).
Demand of spiritual self-care smartphone app
Time frame: Week 10
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).
7 secondary outcomes
Expectancy ratings of spiritual self-care smartphone app
Time frame: Baseline
Spiritual Wellbeing Scores
Time frame: Baseline, Week 6, and Week 10 (follow-up)
Life Satisfaction Scores
Time frame: Baseline, Week 6, and Week 10 (follow-up)
Positive Affect Scores
Time frame: Baseline, Week 6, and Week 10 (follow-up)
Self-Efficacy Scores
Time frame: Baseline, Week 6, and Week 10 (follow-up)
Health-Related Quality of Life Scores
Time frame: Baseline, Week 6, and Week 10 (follow-up)
Qualitative Interviews
Time frame: Week 6
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Individual participant dataSharing planned: No. Pilot data that is descriptive in nature
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John M Salsman, PhD principal investigator
Wake Forest University Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Spiritual Self-Care Smartphone App in people with Cancer and Young Adult Cancer, run by Wake Forest University Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of spiritual self-care smartphone app (time frame: Week 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.