Cancer SurvivorNCT02699996

Peer Mentoring in Promoting Follow-up Care Self-Management in Younger Childhood Cancer Survivors

A study testing Questionnaire Administration and Telephone-Based Intervention in people with Cancer Survivor, run by Rutgers, The State University of New Jersey at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 29 years
Conditions the study is for: Cancer Survivor
What is being tested?: Questionnaire Administration and Telephone-Based Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 1 siteUnited States
Study dates: 14 Jan 2016to 7 May 2018
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 29 years
All sexes
No healthy volunteers
Adult

Who may be able to join

PEER MENTOR ELIGIBILITY:
Age 21-29
At least 1.5 years from treatment
Self-reported primary responsibility for care and "complete readiness" using the Readiness for Transition Questionnaire
PATIENT ELIGIBILITY:
Age 18-25
At least 1.5 years from treatment
Currently does not independently self-manage follow-up care according to self-report to assume total responsibility for care (i.e., reports low readiness [score of 1 or 2 out of 4] OR scores <3 on any of the 10-item responsibility scale from the Readiness for Transition Questionnaire)

Who cannot join

PATIENT EXCLUSION CRITERIA: Physician- or self-reported cognitive delay or impairment that would prevent self-management of healthcare

Trial locations and contacts

1 site in 1 country.

United States1 site

Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903

Other trials in United States

About this study

Official title: Promoting Follow-Up Care Self-Management for Adolescent and Young Adult (AYA) Childhood Cancer Survivors

This pilot trial studies a peer mentoring and online self-management program to see how well it works in promoting follow-up care self-management in younger childhood cancer survivors. Childhood cancer survivors require lifelong follow-up care to identify, monitor, and treat medical and psychosocial late effects stemming from their cancer, its treatment, and lifestyle factors. A peer mentoring program + self-management may improve disease knowledge, health motivation, problem-solving skills, stress management, and communication with caregivers and providers in adolescent and young adult cancer survivors.

Read the detailed description

PRIMARY OBJECTIVES:

Evaluate the feasibility of the self-management + peer mentoring program in a pilot trial.

II. Assess preliminary outcomes of the peer mentoring program.

OUTLINE:

All Participants will be asked to complete online self-management educational modules and 6 weekly peer mentor calls to facilitate engagement with the online modules and offer specialized support. We will also recruit and train peer Mentors.

Conditions: Cancer Survivor
Being tested: Questionnaire Administration, Telephone-Based Intervention
Keywords: Cancer Survivor, Young Adult, Peer Mentor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Questionnaire AdministrationOther
Complete interview
Telephone-Based InterventionBehavioural
Complete the self management + peer mentoring intervention with videoconferencing

Study groups in NCT02699996
Study group	Role	What they receive
self-management + peer mentoring	Experimental	Participants complete the self-management + peer mentoring intervention comprising 5 online educational modules and 6 videoconference or phone calls with the peer mentor. Receives: Other: Questionnaire Administration; Behavioral: Telephone-Based Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility as Measured by Study Enrollment Rates, Retention Rates, Adherence to the Intervention, and Reasons for Study Drop Out.
Descriptive analyses will be used to evaluate expected enrollment (> 50%), retention (> 80%), and completion of intervention sessions (> 75%).
Measured: 6 weeks
Satisfaction With Intervention, Measured by 1) General Satisfaction, 2) Intervention Utility Questionnaire, 3) Impact Questionnaire (i.e., Effectiveness), and 4) Adherence Questionnaire ( i.e., Barriers to Engagement).
1. General Satisfaction: Average of each item reported separately. 1: Program; 2: Online educational materials; 3: Discussion with mentor; 4: Frequency of calls; 5: Program duration; 6: Material read. Items 1, 2, 3, \& 6 are rated on a 1 "not at all" to 5 "very" scale (higher=higher satisfaction). Item 4 uses a 1 "not frequent enough" to 3 "too frequent" scale. Item 5 uses a 1 "way too short" to 5 "way too long" scale.
2. 12-items adapted from Internet Intervention Utility Questionnaire; measures perceived usefulness on 1 "not at all" to 5 "very" scale, higher=higher usefulness. Average total score reported.
3. 16-item Impact Questionnaire measures perceived effectiveness in improving targeted skills using 1 "not at all" to 5 "very" scale (higher=greater perceived effectiveness). Average total score reported.
4. 6-item Adherence Questionnaire measures barriers to engagement using 1 "not a problem" to 3 "major problem" scale. (higher=bigger barrier). Average total score reported.
Measured: 6 weeks (post-intervention)
Mentor Training Satisfaction
Mentor 6-item Training Satisfaction measured on a scale from 1 "strongly disagree" to 4 "strongly agree" (higher score=high satisfaction). Administered to Group Intervention Mentors only. Total average score is reported.
Measured: Time of enrollment, after completing mentor training.

Secondary outcomes (8)

Transition Readiness, as Measured by the Readiness for Transition Questionnaire - Survivor Version
Respondents rate how responsible they are for various healthcare tasks on a 4-point scale, where 1= "not responsible at all", and 4= "almost always responsible." The Adolescent Responsibility Scale is calculated by averaging responses across all 10 items (RTQ-Survivor). A single item assessing "overall readiness to assume complete responsibility for health care" on the same 4-point scale is analyzed separately.
Measured: Baseline to up to 6 weeks
Transition Readiness, as Measured by the Transition Readiness Inventory (Phase 2).
The Transition Readiness Inventory (TRI) yields six sub-scale scores: Knowledge, Skills/Self-Efficacy, Beliefs/Expectations, Goals/Motivation, Relationship/Communication, and Psychosocial/Emotional. Total average score is reported across all sub-scales (TRI-total), as well as each sub-scale total score. Scores are averaged across items on a 5-point scale from 1 "not at all" to 5 "extremely" or "always," with higher scores indicating better functioning.
Measured: Baseline to up to 6 weeks
Symptoms of Depression, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short-Form (v1.0 8b).
Respondents report symptoms on a 5-point rating scale from 1 "never" to 5 "always" in the past 7 days, with higher scores indicating higher levels of negative affect. A total raw summary score is calculated and then translated into a standardized T-score with a mean of 50 and standard deviation of 10.
Measured: Baseline to up to 6 weeks
Symptoms of Anxiety, as Measured by the PROMIS Anxiety Short-Form (v1.0 8a)
Respondents report symptoms on a 5-point rating scale from 1 "never" to 5 "always" in the past 7 days, with higher scores indicating higher levels of negative affect. A total raw summary score is calculated and then translated into a standardized T-score with a mean of 50 and standard deviation of 10.
Measured: Baseline to up to 6 weeks
Cancer Related Worry Scale
This 4-item scale is measuring cancer-related worries (i.e., recurrence of cancer, future diagnostic tests, cancer coming back, other type of cancer). A total score is calculated by averaging across items on a 5-point scale (from 1="Strongly disagree" to 5="Strongly agree"), with higher scores indicating greater worry. Total average score is reported.
Measured: Baseline to up to 6 weeks
Short Grit Scale
Perseverance is measured via the The Short Grit Scale, an 8-item measure of perseverance for long-term goals. A total scale score is calculated by averaging across all items, on a 5-point scale (from 1 "not at all like me" to 5 "very much like me"), with higher scores indicating greater perseverance.
Measured: Baseline to up to 6 weeks
Impact of Cancer, as Measured by Three Subscales of the Impact of Cancer - Childhood Cancer Survivors Scale
The three subscales measure perceptions of cancer impact on Body Health (8 items), Personal Growth (5 items), and Memory Problems (4 items). Sub-scales are scored by averaging across items using a 5-point scale (where 1="not at all", and 5="very much"), with higher scores indicating greater impact.
Measured: Baseline to up to 6 weeks
Barriers to Follow-up Care & Adherence
Barriers to follow-up care \& adherence evaluated by insurance status, current provider, and other barriers to care using 6 items from the Follow-Up Care Use and Health Outcomes of Cancer Survivors (FOCUS). Participants report on appointments, cancer screening, and other adherence markers on a 5-point scale (from 1="Strongly disagree" to 5="Strongly agree"), where higher score indicates grater barrier. Total average score is reported.
Measured: Up to 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Jan 20167 May 2018

First posted7 Mar 2016 (estimated)
Study start14 Jan 2016
Primary completion7 May 2018
Study completion7 May 2018

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 Cancer SurvivorStudies of the same condition, open and under way.
More trials run by Rutgers, The State University of New JerseyThe 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: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02699996
Sponsor's protocol ID: Pro20150001955
Other IDs: NCI-2015-02098, Pro20150001955, 131507, P30CA072720
Status last verified: Oct 2022
First submitted: 1 Mar 2016
Last updated: 19 Oct 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Promoting Follow-Up Care Self-Management for Adolescent and Young Adult (AYA) Childhood Cancer Survivors
ClinicalTrials.gov ID: NCT02699996
Acronym / sponsor ID: Pro20150001955
Conditions: Cancer Survivor
Keywords: Cancer Survivor, Young Adult, Peer Mentor
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: Rutgers, The State University of New JerseyUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 14 Jan 2016 (actual)
Primary completion: 7 May 2018 (actual)
Study completion: 7 May 2018 (actual)
First posted: 7 Mar 2016 (estimated)
Results: Posted 10 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

Evaluate the feasibility of the self-management + peer mentoring program in a pilot trial.

II. Assess preliminary outcomes of the peer mentoring program.

OUTLINE:

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
self-management + peer mentoring	Experimental	Other: Questionnaire Administration, Behavioral: Telephone-Based InterventionParticipants complete the self-management + peer mentoring intervention comprising 5 online educational modules and 6 videoconference or phone calls with the peer mentor.

Who may qualify

Ages: 18 to 29 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Age 21-29
At least 1.5 years from treatment
Self-reported primary responsibility for care and "complete readiness" using the Readiness for Transition Questionnaire
Age 18-25
At least 1.5 years from treatment

Key exclusion criteria (1 listed)

PATIENT EXCLUSION CRITERIA: Physician- or self-reported cognitive delay or impairment that would prevent self-management of healthcare

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
Questionnaire AdministrationComplete interview	Other	self-management + peer mentoring
Telephone-Based InterventionComplete the self management + peer mentoring intervention with videoconferencing	Behavioural	self-management + peer mentoring

Primary outcome

Feasibility as Measured by Study Enrollment Rates, Retention Rates, Adherence to the Intervention, and Reasons for Study Drop Out.
Time frame: 6 weeks
Descriptive analyses will be used to evaluate expected enrollment (> 50%), retention (> 80%), and completion of intervention sessions (> 75%).
Satisfaction With Intervention, Measured by 1) General Satisfaction, 2) Intervention Utility Questionnaire, 3) Impact Questionnaire (i.e., Effectiveness), and 4) Adherence Questionnaire ( i.e., Barriers to Engagement).
Time frame: 6 weeks (post-intervention)
1. General Satisfaction: Average of each item reported separately. 1: Program; 2: Online educational materials; 3: Discussion with mentor; 4: Frequency of calls; 5: Program duration; 6: Material read. Items 1, 2, 3, \& 6 are rated on a 1 "not at all" to 5 "very" scale (higher=higher satisfaction). Item 4 uses a 1 "not frequent enough" to 3 "too frequent" scale. Item 5 uses a 1 "way too short" to 5 "way too long" scale. 2. 12-items adapted from Internet Intervention Utility Questionnaire; measures perceived usefulness on 1 "not at all" to 5 "very" scale, higher=higher usefulness. Average total score reported. 3. 16-item Impact Questionnaire measures perceived effectiveness in improving targeted skills using 1 "not at all" to 5 "very" scale (higher=greater perceived effectiveness). Average total score reported. 4. 6-item Adherence Questionnaire measures barriers to engagement using 1 "not a problem" to 3 "major problem" scale. (higher=bigger barrier). Average total score reported.
Mentor Training Satisfaction
Time frame: Time of enrollment, after completing mentor training.
Mentor 6-item Training Satisfaction measured on a scale from 1 "strongly disagree" to 4 "strongly agree" (higher score=high satisfaction). Administered to Group Intervention Mentors only. Total average score is reported.

8 secondary outcomes

Transition Readiness, as Measured by the Readiness for Transition Questionnaire - Survivor Version
Time frame: Baseline to up to 6 weeks
Transition Readiness, as Measured by the Transition Readiness Inventory (Phase 2).
Time frame: Baseline to up to 6 weeks
Symptoms of Depression, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short-Form (v1.0 8b).
Time frame: Baseline to up to 6 weeks
Symptoms of Anxiety, as Measured by the PROMIS Anxiety Short-Form (v1.0 8a)
Time frame: Baseline to up to 6 weeks
Cancer Related Worry Scale
Time frame: Baseline to up to 6 weeks
Short Grit Scale
Time frame: Baseline to up to 6 weeks
Impact of Cancer, as Measured by Three Subscales of the Impact of Cancer - Childhood Cancer Survivors Scale
Time frame: Baseline to up to 6 weeks
Barriers to Follow-up Care & Adherence
Time frame: Up to 6 weeks

Results and safety

Results posted to the registry on 10 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group Intervention Participants	20	15
Group Intervention Mentors	11	9

Primary outcome: Feasibility as Measured by Study Enrollment Rates, Retention Rates, Adherence to the Intervention, and Reasons for Study Drop Out.

Time frame: 6 weeks. Count of participants. Unit: Participants

Measure	Group Intervention Participants n = 36	Group Intervention Mentors n = 11
Study Enrollment Rates: Eligible on study	20	11
Study Enrollment Rates: Ineligible	8	0
Study Enrollment Rates: Declined participation/No time	1	0
Study Enrollment Rates: Unable to reach	7	0
Reason Study Drop Out: Eligible on study	0	0
Reason Study Drop Out: Ineligible	0	0
Reason Study Drop Out: Declined participation/No time	1	2
Reason Study Drop Out: Unable to reach	4	0

Population analysed: Group Intervention Participants: the total number of potential participants identified by the Cancer Registry, whose contact information was provided to our study team for recruitment. Group Intervention Mentors-identified and recommended by the local survivorship clinic physicians and clinical staff.

Primary outcome: Satisfaction With Intervention, Measured by 1) General Satisfaction, 2) Intervention Utility Questionnaire, 3) Impact Questionnaire (i.e., Effectiveness), and 4) Adherence Questionnaire ( i.e., Barriers to Engagement).

Time frame: 6 weeks (post-intervention). Mean (Standard Deviation). Unit: score on a scale

Measure	Group Intervention Participants n = 15
Satisfaction w/Program [Range 1-5]	4.20 (0.86)
Satisfaction w/Online materials [Range 1-5]	3.80 (1.01)
Satisfaction w/Discussions [Range 1-5]	4.60 (0.63)
Frequency of calls [Range 1-3; 2="Just right"]	2.0 (0.39)
Program duration [Range 1-5;3="Just right"]	3.07 (0.59)
Amount of ed materials read [Range 1-5]	3.80 (1.01)
Internet Utility Total Score [Range 1-5]	3.96 (0.69)
Impact Questionnaire Total Score [Range 1-5]	3.81 (0.90)

Population analysed: Satisfaction with intervention, administered to all Participants, i.e., Group Intervention Participants, n=15.

Primary outcome: Mentor Training Satisfaction

Time frame: Time of enrollment, after completing mentor training.. Mean (Standard Deviation). Unit: score on a scale

Measure	Group Intervention Mentors n = 11
Value	3.92 (0.16)

Population analysed: Mentors completed satisfaction with training questionnaire after completion of the Mentor Training and prior to being matched with a participant (mentee).

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: For the study duration, i.e., ~6 weeks for each participant.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group Intervention Participants	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Group Intervention Mentors	0 of 11 (0%)	0 of 11 (0%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
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 Devine principal investigator

Rutgers Cancer Institute of New Jersey

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Questionnaire Administration and Telephone-Based Intervention in people with Cancer Survivor, run by Rutgers, The State University of New Jersey 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 8 inclusion and 1 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: finished, as of the sponsor's last update on 19 Oct 2022. 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 10 Aug 2020). 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?

Feasibility as Measured by Study Enrollment Rates, Retention Rates, Adherence to the Intervention, and Reasons for Study Drop Out. (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02699996.

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 19 Oct 2022.