Cancer Survivor
Conditions
Keywords
Cancer Survivor, Young Adult, Peer Mentor
Brief summary
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.
Detailed description
PRIMARY OBJECTIVES: I. 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.
Interventions
OTHERQuestionnaire Administration
Complete interview
BEHAVIORALTelephone-Based Intervention
Complete the self management + peer mentoring intervention with videoconferencing
Sponsors
National Cancer Institute (NCI)
Rutgers, The State University of New Jersey
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 29 Years
Healthy volunteers
No
Inclusion criteria
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)
Exclusion criteria
PATIENT
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility as Measured by Study Enrollment Rates, Retention Rates, Adherence to the Intervention, and Reasons for Study Drop Out. | 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). | 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 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms of Anxiety, as Measured by the PROMIS Anxiety Short-Form (v1.0 8a) | Baseline to up to 6 weeks | 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. |
| Cancer Related Worry Scale | Baseline to up to 6 weeks | 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. |
| Transition Readiness, as Measured by the Readiness for Transition Questionnaire - Survivor Version | Baseline to up to 6 weeks | 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. |
| Impact of Cancer, as Measured by Three Subscales of the Impact of Cancer - Childhood Cancer Survivors Scale | Baseline to up to 6 weeks | 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. |
| Barriers to Follow-up Care & Adherence | Up to 6 weeks | 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. |
| Short Grit Scale | Baseline to up to 6 weeks | 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. |
| Transition Readiness, as Measured by the Transition Readiness Inventory (Phase 2). | Baseline to up to 6 weeks | 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. |
| Symptoms of Depression, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short-Form (v1.0 8b). | Baseline to up to 6 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group Intervention Participants one arm, all participants complete 6 week self-management (5 online educational modules) + peer mentoring (6 video-conference or phone calls) intervention. | 20 |
| Group Intervention Mentors one arm, all participants complete 6 week self-management (5 online educational modules) + peer mentoring (6 video-conference or phone calls) intervention. | 11 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 5 | 2 |
Baseline characteristics
| Characteristic | Group Intervention Participants | Group Intervention Mentors | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 11 Participants | 31 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 17 Participants | 10 Participants | 27 Participants |
| Region of Enrollment United States | 20 participants | 11 participants | 31 participants |
| Sex: Female, Male Female | 9 Participants | 5 Participants | 14 Participants |
| Sex: Female, Male Male | 11 Participants | 6 Participants | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 11 |
| other Total, other adverse events | 0 / 20 | 0 / 11 |
| serious Total, serious adverse events | 0 / 20 | 0 / 11 |
Outcome results
Primary
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%).
Time frame: 6 weeks
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Group Intervention Participants | Feasibility as Measured by Study Enrollment Rates, Retention Rates, Adherence to the Intervention, and Reasons for Study Drop Out. | Study Enrollment Rates | Eligible on study | 20 Participants |
| Group Intervention Participants | Feasibility as Measured by Study Enrollment Rates, Retention Rates, Adherence to the Intervention, and Reasons for Study Drop Out. | Participant Retention Rates | Eligible on study | 15 Participants |
| Group Intervention Participants | Feasibility as Measured by Study Enrollment Rates, Retention Rates, Adherence to the Intervention, and Reasons for Study Drop Out. | Reason Study Drop Out | Eligible on study | 0 Participants |
| Group Intervention Participants | Feasibility as Measured by Study Enrollment Rates, Retention Rates, Adherence to the Intervention, and Reasons for Study Drop Out. | Participant Retention Rates | Ineligible | 0 Participants |
| Group Intervention Participants | Feasibility as Measured by Study Enrollment Rates, Retention Rates, Adherence to the Intervention, and Reasons for Study Drop Out. | Study Enrollment Rates | Declined participation/No time | 1 Participants |
| Group Intervention Participants | Feasibility as Measured by Study Enrollment Rates, Retention Rates, Adherence to the Intervention, and Reasons for Study Drop Out. | Participant Retention Rates | Declined participation/No time | 1 Participants |
| Group Intervention Participants | Feasibility as Measured by Study Enrollment Rates, Retention Rates, Adherence to the Intervention, and Reasons for Study Drop Out. | Reason Study Drop Out | Ineligible | 0 Participants |
| Group Intervention Participants | Feasibility as Measured by Study Enrollment Rates, Retention Rates, Adherence to the Intervention, and Reasons for Study Drop Out. | Participant Retention Rates | Unable to reach | 4 Participants |
| Group Intervention Participants | Feasibility as Measured by Study Enrollment Rates, Retention Rates, Adherence to the Intervention, and Reasons for Study Drop Out. | Study Enrollment Rates | Ineligible | 8 Participants |
| Group Intervention Participants | Feasibility as Measured by Study Enrollment Rates, Retention Rates, Adherence to the Intervention, and Reasons for Study Drop Out. | Adherence to Sessions | Eligible on study | 15 Participants |
| Group Intervention Participants | Feasibility as Measured by Study Enrollment Rates, Retention Rates, Adherence to the Intervention, and Reasons for Study Drop Out. | Reason Study Drop Out | Declined participation/No time | 1 Participants |
| Group Intervention Participants | Feasibility as Measured by Study Enrollment Rates, Retention Rates, Adherence to the Intervention, and Reasons for Study Drop Out. | Adherence to Sessions | Ineligible | 0 Participants |
| Group Intervention Participants | Feasibility as Measured by Study Enrollment Rates, Retention Rates, Adherence to the Intervention, and Reasons for Study Drop Out. | Study Enrollment Rates | Unable to reach | 7 Participants |
| Group Intervention Participants | Feasibility as Measured by Study Enrollment Rates, Retention Rates, Adherence to the Intervention, and Reasons for Study Drop Out. | Adherence to Sessions | Declined participation/No time | 0 Participants |
| Group Intervention Participants | Feasibility as Measured by Study Enrollment Rates, Retention Rates, Adherence to the Intervention, and Reasons for Study Drop Out. | Reason Study Drop Out | Unable to reach | 4 Participants |
| Group Intervention Participants | Feasibility as Measured by Study Enrollment Rates, Retention Rates, Adherence to the Intervention, and Reasons for Study Drop Out. | Adherence to Sessions | Unable to reach | 0 Participants |
| Group Intervention Mentors | Feasibility as Measured by Study Enrollment Rates, Retention Rates, Adherence to the Intervention, and Reasons for Study Drop Out. | Adherence to Sessions | Unable to reach | 0 Participants |
| Group Intervention Mentors | Feasibility as Measured by Study Enrollment Rates, Retention Rates, Adherence to the Intervention, and Reasons for Study Drop Out. | Study Enrollment Rates | Eligible on study | 11 Participants |
| Group Intervention Mentors | Feasibility as Measured by Study Enrollment Rates, Retention Rates, Adherence to the Intervention, and Reasons for Study Drop Out. | Study Enrollment Rates | Ineligible | 0 Participants |
| Group Intervention Mentors | Feasibility as Measured by Study Enrollment Rates, Retention Rates, Adherence to the Intervention, and Reasons for Study Drop Out. | Study Enrollment Rates | Declined participation/No time | 0 Participants |
| Group Intervention Mentors | Feasibility as Measured by Study Enrollment Rates, Retention Rates, Adherence to the Intervention, and Reasons for Study Drop Out. | Study Enrollment Rates | Unable to reach | 0 Participants |
| Group Intervention Mentors | Feasibility as Measured by Study Enrollment Rates, Retention Rates, Adherence to the Intervention, and Reasons for Study Drop Out. | Reason Study Drop Out | Eligible on study | 0 Participants |
| Group Intervention Mentors | Feasibility as Measured by Study Enrollment Rates, Retention Rates, Adherence to the Intervention, and Reasons for Study Drop Out. | Reason Study Drop Out | Ineligible | 0 Participants |
| Group Intervention Mentors | Feasibility as Measured by Study Enrollment Rates, Retention Rates, Adherence to the Intervention, and Reasons for Study Drop Out. | Reason Study Drop Out | Declined participation/No time | 2 Participants |
| Group Intervention Mentors | Feasibility as Measured by Study Enrollment Rates, Retention Rates, Adherence to the Intervention, and Reasons for Study Drop Out. | Reason Study Drop Out | Unable to reach | 0 Participants |
| Group Intervention Mentors | Feasibility as Measured by Study Enrollment Rates, Retention Rates, Adherence to the Intervention, and Reasons for Study Drop Out. | Participant Retention Rates | Eligible on study | 9 Participants |
| Group Intervention Mentors | Feasibility as Measured by Study Enrollment Rates, Retention Rates, Adherence to the Intervention, and Reasons for Study Drop Out. | Participant Retention Rates | Ineligible | 0 Participants |
| Group Intervention Mentors | Feasibility as Measured by Study Enrollment Rates, Retention Rates, Adherence to the Intervention, and Reasons for Study Drop Out. | Participant Retention Rates | Declined participation/No time | 2 Participants |
| Group Intervention Mentors | Feasibility as Measured by Study Enrollment Rates, Retention Rates, Adherence to the Intervention, and Reasons for Study Drop Out. | Participant Retention Rates | Unable to reach | 0 Participants |
| Group Intervention Mentors | Feasibility as Measured by Study Enrollment Rates, Retention Rates, Adherence to the Intervention, and Reasons for Study Drop Out. | Adherence to Sessions | Eligible on study | 9 Participants |
| Group Intervention Mentors | Feasibility as Measured by Study Enrollment Rates, Retention Rates, Adherence to the Intervention, and Reasons for Study Drop Out. | Adherence to Sessions | Ineligible | 0 Participants |
| Group Intervention Mentors | Feasibility as Measured by Study Enrollment Rates, Retention Rates, Adherence to the Intervention, and Reasons for Study Drop Out. | Adherence to Sessions | Declined participation/No time | 0 Participants |
Primary
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.
Time frame: Time of enrollment, after completing mentor training.
Population: Mentors completed satisfaction with training questionnaire after completion of the Mentor Training and prior to being matched with a participant (mentee).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group Intervention Participants | Mentor Training Satisfaction | 3.92 score on a scale | Standard Deviation 0.16 |
Primary
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.
Time frame: 6 weeks (post-intervention)
Population: Satisfaction with intervention, administered to all Participants, i.e., Group Intervention Participants, n=15.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group Intervention Participants | 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). | Satisfaction w/Program [Range 1-5] | 4.20 score on a scale | Standard Deviation 0.86 |
| Group Intervention Participants | 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). | Satisfaction w/Online materials [Range 1-5] | 3.80 score on a scale | Standard Deviation 1.01 |
| Group Intervention Participants | 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). | Satisfaction w/Discussions [Range 1-5] | 4.60 score on a scale | Standard Deviation 0.63 |
| Group Intervention Participants | 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). | Frequency of calls [Range 1-3; 2=Just right] | 2.0 score on a scale | Standard Deviation 0.39 |
| Group Intervention Participants | 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). | Program duration [Range 1-5;3=Just right] | 3.07 score on a scale | Standard Deviation 0.59 |
| Group Intervention Participants | 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). | Amount of ed materials read [Range 1-5] | 3.80 score on a scale | Standard Deviation 1.01 |
| Group Intervention Participants | 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). | Internet Utility Total Score [Range 1-5] | 3.96 score on a scale | Standard Deviation 0.69 |
| Group Intervention Participants | 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). | Impact Questionnaire Total Score [Range 1-5] | 3.81 score on a scale | Standard Deviation 0.9 |
| Group Intervention Participants | 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). | Adherence Questionnaire Total [Range 1-3] | 1.12 score on a scale | Standard Deviation 0.21 |
Secondary
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.
Time frame: Up to 6 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group Intervention Participants | Barriers to Follow-up Care & Adherence | Barriers pre- | 2.20 score on a scale | Standard Deviation 0.47 |
| Group Intervention Participants | Barriers to Follow-up Care & Adherence | Barriers post- | 2.01 score on a scale | Standard Deviation 0.59 |
p-value: 0.0895% CI: [-0.4, 0.03]t-test, 2 sided
Secondary
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.
Time frame: Baseline to up to 6 weeks
Population: Participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group Intervention Participants | Cancer Related Worry Scale | Cancer Related Worry pre- | 3.72 score on a scale | Standard Deviation 1.2 |
| Group Intervention Participants | Cancer Related Worry Scale | Cancer Related Worry post- | 3.43 score on a scale | Standard Deviation 1.41 |
p-value: 0.2695% CI: [-0.8, 0.23]t-test, 2 sided
Secondary
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.
Time frame: Baseline to up to 6 weeks
Population: Participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group Intervention Participants | Impact of Cancer, as Measured by Three Subscales of the Impact of Cancer - Childhood Cancer Survivors Scale | Body Health pre- | 3.60 score on a scale | Standard Deviation 1.13 |
| Group Intervention Participants | Impact of Cancer, as Measured by Three Subscales of the Impact of Cancer - Childhood Cancer Survivors Scale | Body Health post- | 3.80 score on a scale | Standard Deviation 0.86 |
| Group Intervention Participants | Impact of Cancer, as Measured by Three Subscales of the Impact of Cancer - Childhood Cancer Survivors Scale | Personal Growth pre- | 4.39 score on a scale | Standard Deviation 0.67 |
| Group Intervention Participants | Impact of Cancer, as Measured by Three Subscales of the Impact of Cancer - Childhood Cancer Survivors Scale | Personal Growth post- | 4.25 score on a scale | Standard Deviation 0.58 |
| Group Intervention Participants | Impact of Cancer, as Measured by Three Subscales of the Impact of Cancer - Childhood Cancer Survivors Scale | Memory pre- | 3.02 score on a scale | Standard Deviation 0.43 |
| Group Intervention Participants | Impact of Cancer, as Measured by Three Subscales of the Impact of Cancer - Childhood Cancer Survivors Scale | Memory post- | 3.12 score on a scale | Standard Deviation 0.56 |
Comparison: Body Health Subscalep-value: 0.295% CI: [-0.12, 0.52]t-test, 2 sided
Comparison: Personal Growth Subscalep-value: 0.495% CI: [-0.46, 0.2]t-test, 2 sided
Comparison: Memory Subscalep-value: 0.2995% CI: [-0.09, 0.29]t-test, 2 sided
Secondary
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.
Time frame: Baseline to up to 6 weeks
Population: Participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group Intervention Participants | Short Grit Scale | Grit pre- | 3.29 score on a scale | Standard Deviation 0.63 |
| Group Intervention Participants | Short Grit Scale | Grit post- | 3.57 score on a scale | Standard Deviation 0.58 |
p-value: 0.0395% CI: [0.03, 0.52]t-test, 2 sided
Secondary
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.
Time frame: Baseline to up to 6 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group Intervention Participants | Symptoms of Anxiety, as Measured by the PROMIS Anxiety Short-Form (v1.0 8a) | Anxiety pre- | 59.29 T-score | Standard Deviation 14.2 |
| Group Intervention Participants | Symptoms of Anxiety, as Measured by the PROMIS Anxiety Short-Form (v1.0 8a) | Anxiety post- | 57.55 T-score | Standard Deviation 7.97 |
p-value: 0.4295% CI: [-6.23, 2.75]t-test, 2 sided
Secondary
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.
Time frame: Baseline to up to 6 weeks
Population: We had missing data for one participant, therefore total number of participants analyzed is 14.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group Intervention Participants | Symptoms of Depression, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short-Form (v1.0 8b). | Depression pre- | 52.66 T-score | Standard Deviation 12.15 |
| Group Intervention Participants | Symptoms of Depression, as Measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression Short-Form (v1.0 8b). | Depression post- | 51.02 T-score | Standard Deviation 9.63 |
p-value: 0.5695% CI: [-7.62, 4.34]t-test, 2 sided
Secondary
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.
Time frame: Baseline to up to 6 weeks
Population: All participants who completed baseline assessment, intervention, and follow-up assessment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group Intervention Participants | Transition Readiness, as Measured by the Readiness for Transition Questionnaire - Survivor Version | RTQ-Survivor Adolescent Responsibility pre- | 3.08 score on a scale | Standard Deviation 0.69 |
| Group Intervention Participants | Transition Readiness, as Measured by the Readiness for Transition Questionnaire - Survivor Version | RTQ-Survivor Adolescent Responsibility post- | 3.60 score on a scale | Standard Deviation 0.35 |
| Group Intervention Participants | Transition Readiness, as Measured by the Readiness for Transition Questionnaire - Survivor Version | RTQ-Overall Readiness pre- | 2.60 score on a scale | Standard Deviation 0.74 |
| Group Intervention Participants | Transition Readiness, as Measured by the Readiness for Transition Questionnaire - Survivor Version | RTQ-Overall Readiness post- | 3.27 score on a scale | Standard Deviation 0.7 |
Comparison: RTQ-Survivor Adolescent Responsibility Scorep-value: <0.0195% CI: [0.17, 0.86]t-test, 2 sided
Comparison: RTQ-Overall Readiness Scorep-value: <0.0195% CI: [0.27, 1.07]t-test, 2 sided
Secondary
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.
Time frame: Baseline to up to 6 weeks
Population: Participants who completed baseline, intervention, and follow-up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group Intervention Participants | Transition Readiness, as Measured by the Transition Readiness Inventory (Phase 2). | TRI-total pre- | 4.03 score on a scale | Standard Deviation 0.41 |
| Group Intervention Participants | Transition Readiness, as Measured by the Transition Readiness Inventory (Phase 2). | TRI-total post- | 4.27 score on a scale | Standard Deviation 0.23 |
| Group Intervention Participants | Transition Readiness, as Measured by the Transition Readiness Inventory (Phase 2). | TRI Knowledge pre- | 4.21 score on a scale | Standard Deviation 0.63 |
| Group Intervention Participants | Transition Readiness, as Measured by the Transition Readiness Inventory (Phase 2). | TRI Knowledge post- | 4.70 score on a scale | Standard Deviation 0.37 |
| Group Intervention Participants | Transition Readiness, as Measured by the Transition Readiness Inventory (Phase 2). | TRI Skills/Self-Efficacy pre- | 3.97 score on a scale | Standard Deviation 0.65 |
| Group Intervention Participants | Transition Readiness, as Measured by the Transition Readiness Inventory (Phase 2). | TRI Skills/Self-Efficacy post- | 4.27 score on a scale | Standard Deviation 0.47 |
| Group Intervention Participants | Transition Readiness, as Measured by the Transition Readiness Inventory (Phase 2). | TRI Beliefs/Expectations pre- | 3.93 score on a scale | Standard Deviation 0.39 |
| Group Intervention Participants | Transition Readiness, as Measured by the Transition Readiness Inventory (Phase 2). | TRI Beliefs/Expectations post- | 4.06 score on a scale | Standard Deviation 0.34 |
| Group Intervention Participants | Transition Readiness, as Measured by the Transition Readiness Inventory (Phase 2). | TRI Goals/Motivation pre- | 4.15 score on a scale | Standard Deviation 0.77 |
| Group Intervention Participants | Transition Readiness, as Measured by the Transition Readiness Inventory (Phase 2). | TRI Goals/Motivation post- | 4.55 score on a scale | Standard Deviation 0.54 |
| Group Intervention Participants | Transition Readiness, as Measured by the Transition Readiness Inventory (Phase 2). | TRI Relationship/Communication pre- | 4.23 score on a scale | Standard Deviation 0.4 |
| Group Intervention Participants | Transition Readiness, as Measured by the Transition Readiness Inventory (Phase 2). | TRI Relationship/Communication post- | 4.28 score on a scale | Standard Deviation 0.4 |
| Group Intervention Participants | Transition Readiness, as Measured by the Transition Readiness Inventory (Phase 2). | TRI Psychosocial/Emotional pre- | 3.69 score on a scale | Standard Deviation 0.73 |
| Group Intervention Participants | Transition Readiness, as Measured by the Transition Readiness Inventory (Phase 2). | TRI Psychosocial/Emotional post- | 3.79 score on a scale | Standard Deviation 0.4 |
Comparison: TRI-total Scorep-value: 0.0295% CI: [0.05, 0.42]t-test, 2 sided
Comparison: TRI Knowledge scorep-value: <0.0195% CI: [0.26, 0.73]t-test, 2 sided
Comparison: TRI Skills/Self-Efficacy Scorep-value: 0.05395% CI: [-0.0044, 0.6]t-test, 2 sided
Comparison: TRI Beliefs/Expectations scorep-value: 0.0395% CI: [0.02, 0.24]t-test, 2 sided
Comparison: TRI Goals/Motivation scorep-value: <0.0195% CI: [0.11, 0.69]t-test, 2 sided
Comparison: Relationship/Communication Scorep-value: 0.6195% CI: [-0.16, 0.26]t-test, 2 sided
Comparison: TRI Psychosocial/Emotional Scorep-value: 0.6595% CI: [-0.37, 0.57]t-test, 2 sided