CancerNCT04659993
Cancer Within a Pandemic: A Telemental Health Intervention
A study testing Telemental Health Sessions, Support Groups and Questionnaires in people with Cancer and Survivorship, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this research study is to test an online support group designed to help young adults who have had cancer treatment to manage their mood during a pandemic. Investigators hope to learn more about what effects a support group may have upon the health and well-being of young adults who have undergone cancer… Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Cancer, Survivorship, Depression, Anxiety
- What is being tested?
- Telemental Health Sessions, Support Groups and Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2021to 9 Jun 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Documented cancer diagnosis within the Wake Forest Baptist Medical Center medical record;
- Outpatient Cancer Survivor (diagnosis, treatment, or post-treatment);
- Aged 18-39
- Must speak English
- Must have computer with audio and visual capabilities.
- Must live within North Carolina
- Must have experienced health-related anxiety and/or distress in last 3 months.
Who cannot join
- Exclusion criteria will be determined by pre-screening data and medical chart reviews
- Active inpatient hospitalization
- Major cognitive impairment, marked concerns with working memory, concentration, or word finding difficulties that significantly impairs daily functioning documented in most recent clinic note or self-reported
- Recent suicide attempt(s), psychiatric hospitalization, or psychotic processing (last 3 years)
- Bipolar disorder (I or II) diagnosis, as evidenced by an ICD-10 code within the past year or revealed during subject interview
- Moderate to severe alcohol or drug abuse; as evidenced by an ICD-10 codes related to alcohol or illicit substance abuse in the medical record within the past year or revealed during subject interview.
- Severe eating disorders; as evidenced by an ICD-10 code in the medical record such as anorexia nervosa or bulimia within the past year or revealed during patient interview
- Repeated "acute" crises for example: repeated acute crises consisting of marked psychological distress that impairs function and warrants clinician intervention (e.g., occurring once a month or more frequently); this we be evaluated by the clinician screener.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Cancer Within a Pandemic: A Telemental Health Intervention Designed to Augment Psychological Resilience Amidst Dual Health Threats
The purpose of this research study is to test an online support group designed to help young adults who have had cancer treatment to manage their mood during a pandemic. Investigators hope to learn more about what effects a support group may have upon the health and well-being of young adults who have undergone cancer treatment by offering an online support group that teaches healthy coping skills in a practical and acceptable way. Investigators would also like to know if certain parts of the online material is more effective in helping subjects manage their mood.
Read the detailed description
Primary Objective: To improve self-efficacy for young adult cancer survivors navigating pandemic conditions.
Secondary Objective: To reduce depression and anxiety levels through meaning-making.
- Conditions
- Cancer, Survivorship, Depression, Anxiety
- Being tested
- Telemental Health Sessions, Support Groups and Questionnaires
- Keywords
- Telemental intervention
- Medical subject headings
- Neoplasms, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemental Health Sessions, Support Groups and QuestionnairesBehavioural
Participants will complete initial online questionnaires lasting about 25-30 minutes as well as attend weekly support group meetings online. After 4 weeks, participants will complete seven online follow-up questionnaires that should take no longer than 30 minutes and again at the end of the study.
| Study group | Role | What they receive |
|---|---|---|
| Telemental Group | Experimental | The virtual group will be conducted within a secure platform such as Microsoft WebEx. Assessments (pre-, post-, mid-way) will be distributed through REDCap, a secure virtual platform, as will session handouts and forms. Receives: Behavioral: Telemental Health Sessions, Support Groups and Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Self-Efficacy in Pandemic Conditions
The improvement of self-efficacy for young adult cancer survivors navigating pandemic conditions will be assessed by comparing the change in the Cancer Behaviour Inventory-Brief (CBI-B) version (a 12-item validated questionnaire used widely as a measure of self-efficacy for coping with cancer) from baseline to Visit 8. To test the change over the 8 weeks, a paired t-test (using the baseline and Visit 8 scores within the same patient) will be used; the expected difference in the CBI-B between the two scores would be no change. Score range is 1 (not at all confident) to 9 (totally confident) (minimum score of 12, maximum score of 108). Sum the scores for the 12 items with higher scores indicating greater coping efficacy.
Measured: At baseline up to 8 weeks
Secondary outcomes (3)
Changes in Depression and Anxiety Levels (CAS)
Three instruments will provide information on baseline, Visit 8, and change over time.
- The Coronavirus Anxiety Scale (CAS) - 5-item mental health screener of dysfunctional anxiety associated with the coronavirus. Scoring is on a 5-point scale of 0 (not at all) to 4 (nearly every day). Minimum score (0): A score of 0 indicates that a person has not experienced any dysfunctional anxiety symptoms related to the coronavirus within the past two weeks. Maximum score (20): A score of 20 indicates the highest level of coronavirus-related anxiety, with the individual experiencing all five symptoms "nearly every day" over the past two weeks.
Measured: At baseline up to 8 weeks
Changes in Depression and Anxiety Levels (PIL)
Three instruments will provide information on baseline, Visit 8, and change over time.
- The Purpose in Life Test (PIL) - 20-item, 7-point Likert scale designed to measure the extent to which a respondent perceives a general sense of meaning and purpose in life using varying scale labels, scores are aggregated with a minimum score of 20 (lowest purpose) and a maximum score of 140 (highest purpose).
Measured: At baseline up to 8 weeks
Changes in Depression and Anxiety Levels (MAC)
Three instruments will provide information on baseline, Visit 8, and change over time.
- Mini-Mental Adjustments to Cancer - 29-item, 4-point Likert scale (maximum possible score of 116 and minimum possible score of 29) for rapid assessment of present coping style from 1 (Definitely Does Not Apply to Me) to 4 (Definitely Apply to Me), higher score represents higher endorsement of the adjustment response. (4). Five subscales include: Helpless-Hopeless (score range 8-32), Anxious Preoccupation (score range 8-32), Cognitive Avoidance (score range 4-16), Fighting Spirit (score range 4-16) and Fatalism (score range 5-20).
Measured: At baseline up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start10 Mar 2021
- Primary completion9 Jun 2021
- Study completion9 Jun 2021
Why it stopped: Low accruals
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Katie Duckworth, Ph.D, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04659993
- Sponsor's protocol ID
- IRB00070150
- Other IDs
- WFBCCC01520, P30CA012197
- Status last verified
- Sep 2025
- First submitted
- 2 Dec 2020
- Last updated
- 16 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Within a Pandemic: A Telemental Health Intervention Designed to Augment Psychological Resilience Amidst Dual Health Threats
- ClinicalTrials.gov ID
- NCT04659993
- Acronym / sponsor ID
- IRB00070150
- Conditions
- Cancer, Survivorship, Depression, Anxiety
- Keywords
- Telemental intervention
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accruals
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 9 Jun 2021 (actual)
- Study completion
- 9 Jun 2021 (actual)
- First posted
- 9 Dec 2020 (actual)
- Results
- Posted 16 Oct 2025
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 test an online support group designed to help young adults who have had cancer treatment to manage their mood during a pandemic. Investigators hope to learn more about what effects a support group may have upon the health and well-being of young adults who have undergone cancer treatment by offering an online support group that teaches healthy coping skills in a practical and acceptable way. Investigators would also like to know if certain parts of the online material is more effective in helping subjects manage their mood.
Detailed description
Primary Objective: To improve self-efficacy for young adult cancer survivors navigating pandemic conditions.
Secondary Objective: To reduce depression and anxiety levels through meaning-making.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telemental Group | Experimental | Behavioral: Telemental Health Sessions, Support Groups and QuestionnairesThe virtual group will be conducted within a secure platform such as Microsoft WebEx. Assessments (pre-, post-, mid-way) will be distributed through REDCap, a secure virtual platform, as will session handouts and forms. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Documented cancer diagnosis within the Wake Forest Baptist Medical Center medical record;
- Outpatient Cancer Survivor (diagnosis, treatment, or post-treatment);
- Aged 18-39
- Must speak English
- Must have computer with audio and visual capabilities.
Key exclusion criteria (8 listed)
- Exclusion criteria will be determined by pre-screening data and medical chart reviews
- Active inpatient hospitalization
- Major cognitive impairment, marked concerns with working memory, concentration, or word finding difficulties that significantly impairs daily functioning documented in most recent clinic note or self-reported
- Recent suicide attempt(s), psychiatric hospitalization, or psychotic processing (last 3 years)
- Bipolar disorder (I or II) diagnosis, as evidenced by an ICD-10 code within the past year or revealed during subject interview
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 |
|---|---|---|
| Telemental Health Sessions, Support Groups and QuestionnairesParticipants will complete initial online questionnaires lasting about 25-30 minutes as well as attend weekly support group meetings online. After 4 weeks, participants will complete seven online follow-up questionnaires that should take no longer than 30 minutes and again at the end of the study. | Behavioural | Telemental Group |
Primary outcome
Change in Self-Efficacy in Pandemic Conditions
Time frame: At baseline up to 8 weeks
The improvement of self-efficacy for young adult cancer survivors navigating pandemic conditions will be assessed by comparing the change in the Cancer Behaviour Inventory-Brief (CBI-B) version (a 12-item validated questionnaire used widely as a measure of self-efficacy for coping with cancer) from baseline to Visit 8. To test the change over the 8 weeks, a paired t-test (using the baseline and Visit 8 scores within the same patient) will be used; the expected difference in the CBI-B between the two scores would be no change. Score range is 1 (not at all confident) to 9 (totally confident) (minimum score of 12, maximum score of 108). Sum the scores for the 12 items with higher scores indicating greater coping efficacy.
3 secondary outcomes
Changes in Depression and Anxiety Levels (CAS)
Time frame: At baseline up to 8 weeks
Changes in Depression and Anxiety Levels (PIL)
Time frame: At baseline up to 8 weeks
Changes in Depression and Anxiety Levels (MAC)
Time frame: At baseline up to 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Katie Duckworth, Ph.D principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemental Health Sessions, Support Groups and Questionnaires in people with Cancer and Survivorship, run by Wake Forest University Health Sciences at 1 site in United States.
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 7 inclusion and 8 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: stopped early, as of the sponsor's last update on 16 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 16 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Self-Efficacy in Pandemic Conditions (time frame: At baseline up to 8 weeks). 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 16 Oct 2025.