Cancer Survivor
Conditions
Brief summary
This pilot clinical trial studies how well an internet-delivered positive affect (PA) intervention works in managing emotion in young adult cancer survivors. An internet-delivered PA intervention may teach younger cancer survivors healthy coping skills and help doctors to learn more about what effects mood may have on the health and well-being of young adults with cancer.
Detailed description
PRIMARY OBJECTIVES: I. To adapt an individualized positive affect intervention that was developed for newly diagnosed HIV patients to use with young adult cancer survivors. II. To pilot test the positive affect intervention with young adult cancer survivors to determine its feasibility and acceptability. SECONDARY OBJECTIVES: I. To describe health related quality of life, psychological well-being, daily emotion reports, and health behaviors in young adult cancer survivors. OUTLINE: Patients complete an initial online questionnaire lasting about 25-30 minutes. Patients complete an internet-delivered PA program during weeks 3-8. Each week consists of didactic material and 20-30 minutes of daily online exercises. After completion of study, patients are followed up at 1 and 12 weeks.
Interventions
OTHERInternet-Based Intervention
Complete online PA program
PROCEDUREQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
National Institute of Mental Health (NIMH)
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
* Able to read and understand English * Past history of a cancer diagnosis (excluding basal cell skin carcinoma) * 18 to 39 years of age at diagnosis * Within 0-5 years post-active treatment * Wireless internet connection or a home computer that is connected to the internet
Exclusion criteria
* Evidence of a cancer recurrence * History of multiple primary cancers * Currently receiving palliative or hospice care * Significant psychiatric history
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability - Mean Value | At 12 weeks | Quantitative measures and interview will be used to quantify acceptability. The mean of participants responding affirmatively to the highest two responses from an intervention evaluation phone interview script created by investigators will be combined and exact 95% confidence intervals (CIs) will be calculated for these estimates. Participants were asked the following questions: On a scale of 0 to 10, with 0 being definitely not to 10 being definitely yes, to what extent would you recommend these skills to a friend? and To what extent would you recommend this intervention to someone newly diagnosed with cancer? |
| Acceptability - Proportion Value | At 12 weeks | Quantitative measures and interview will be used to quantify acceptability. The proportion of participants responding affirmatively to the highest two responses from an intervention evaluation phone interview script created by investigators will be combined and exact 95% confidence intervals (CIs) will be calculated for these estimates. Responding affirmatively means a score of 9 or 10 on the scale of 0-10, so the proportion responding affirmatively is the proportion of patients who responded with a 9 or 10 to those questions. Participants were asked the following questions: On a scale of 0 to 10, with 0 being definitely not to 10 being definitely yes, to what extent would you recommend these skills to a friend? and To what extent would you recommend this intervention to someone newly diagnosed with cancer? |
| Accrual | Up to 19 months | Accrual will be estimated as the number of patients accrued divided by the number of months of accrual. A 95% confidence interval for the monthly accrual rate will be calculated based on the Poisson distribution. |
| Adherence - Proportion of Completed Interventions (Mean Value) | At 12 weeks | Adherence to the intervention will be calculated as the number of intervention sessions completed. Investigators will calculate and report the mean adherence across all individuals who completed three or more sessions. |
| Adherence - Proportion of Completed Interventions (Proportion Value) | At 12 weeks | Adherence to the intervention will be calculated as the number of intervention sessions completed. Investigators will calculate and report the proportion of patients who completed three or more sessions. |
| Number of Patients Who Refused to Participate | At 12 weeks | The refusal rate will be estimated as the number of patients who refuse to participate divided by the number eligible. |
| Number of Patient Provided Data at 8 Weeks - Retention | At 8 week | Retention will be defined as the proportion of patients who provide 8 week data. Patients who discontinue the intervention (refuse phone calls) but complete the outcome assessments will be counted in the numerator for calculating retention. Retention estimates will be calculated overall and by site |
| Adherence - Number of Completed Exercises | At 12 weeks | Adherence to the intervention will be calculated as the frequency of completing exercises. Investigators will calculate and report the mean adherence across all individuals as well as the proportion of patients who completed three or more sessions. |
| Number of Website Visits | At 12 weeks | Adherence to the intervention will be calculated as the number of website visits. Investigators will calculate and report the mean adherence across all individuals as well as the proportion of patients who completed three or more sessions. |
| Number of Patients Provided Data at 12 Weeks - Retention | At 12 weeks | Retention will be defined as the number of patients who provide 12 week data. Patients who discontinue the intervention (refuse phone calls) but complete the outcome assessments will be counted in the numerator for calculating retention. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Supportive Care Patients complete an initial online questionnaire lasting about 25-30 minutes. Patients complete an internet-delivered PA program during weeks 3-8. Each week consists of didactic material and 20-30 minutes of daily online exercises.
Internet-Based Intervention: Complete online PA program
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies | 43 |
| Total | 43 |
Baseline characteristics
| Characteristic | Supportive Care |
|---|---|
| Age, Continuous | 30.37 Years STANDARD_DEVIATION 6.62 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 35 Participants |
| Region of Enrollment United States | 43 participants |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 43 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Acceptability - Mean Value
Quantitative measures and interview will be used to quantify acceptability. The mean of participants responding affirmatively to the highest two responses from an intervention evaluation phone interview script created by investigators will be combined and exact 95% confidence intervals (CIs) will be calculated for these estimates. Participants were asked the following questions: On a scale of 0 to 10, with 0 being definitely not to 10 being definitely yes, to what extent would you recommend these skills to a friend? and To what extent would you recommend this intervention to someone newly diagnosed with cancer?
Time frame: At 12 weeks
Population: Only 26 participants out of the 43 were analyzed for acceptability for this outcome.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Supportive Care | Acceptability - Mean Value | 8.81 score on a scale |
Primary
Acceptability - Proportion Value
Quantitative measures and interview will be used to quantify acceptability. The proportion of participants responding affirmatively to the highest two responses from an intervention evaluation phone interview script created by investigators will be combined and exact 95% confidence intervals (CIs) will be calculated for these estimates. Responding affirmatively means a score of 9 or 10 on the scale of 0-10, so the proportion responding affirmatively is the proportion of patients who responded with a 9 or 10 to those questions. Participants were asked the following questions: On a scale of 0 to 10, with 0 being definitely not to 10 being definitely yes, to what extent would you recommend these skills to a friend? and To what extent would you recommend this intervention to someone newly diagnosed with cancer?
Time frame: At 12 weeks
Population: Only 26 participants out of the 43 were analyzed for acceptability for this outcome.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Supportive Care | Acceptability - Proportion Value | 0.58 proportion of participants |
Primary
Accrual
Accrual will be estimated as the number of patients accrued divided by the number of months of accrual. A 95% confidence interval for the monthly accrual rate will be calculated based on the Poisson distribution.
Time frame: Up to 19 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Supportive Care | Accrual | 1.63 participants per month |
Primary
Adherence - Number of Completed Exercises
Adherence to the intervention will be calculated as the frequency of completing exercises. Investigators will calculate and report the mean adherence across all individuals as well as the proportion of patients who completed three or more sessions.
Time frame: At 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Supportive Care | Adherence - Number of Completed Exercises | 5.07 completed exercises | Standard Deviation 3.43 |
Primary
Adherence - Proportion of Completed Interventions (Mean Value)
Adherence to the intervention will be calculated as the number of intervention sessions completed. Investigators will calculate and report the mean adherence across all individuals who completed three or more sessions.
Time frame: At 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Supportive Care | Adherence - Proportion of Completed Interventions (Mean Value) | 3.30 completed interventions | Standard Deviation 2.2 |
Primary
Adherence - Proportion of Completed Interventions (Proportion Value)
Adherence to the intervention will be calculated as the number of intervention sessions completed. Investigators will calculate and report the proportion of patients who completed three or more sessions.
Time frame: At 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Supportive Care | Adherence - Proportion of Completed Interventions (Proportion Value) | 0.63 complete interventions | Standard Deviation 0.48 |
Primary
Number of Patient Provided Data at 8 Weeks - Retention
Retention will be defined as the proportion of patients who provide 8 week data. Patients who discontinue the intervention (refuse phone calls) but complete the outcome assessments will be counted in the numerator for calculating retention. Retention estimates will be calculated overall and by site
Time frame: At 8 week
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Supportive Care | Number of Patient Provided Data at 8 Weeks - Retention | 27 Participants |
Primary
Number of Patients Provided Data at 12 Weeks - Retention
Retention will be defined as the number of patients who provide 12 week data. Patients who discontinue the intervention (refuse phone calls) but complete the outcome assessments will be counted in the numerator for calculating retention.
Time frame: At 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Supportive Care | Number of Patients Provided Data at 12 Weeks - Retention | 27 Participants |
Primary
Number of Patients Who Refused to Participate
The refusal rate will be estimated as the number of patients who refuse to participate divided by the number eligible.
Time frame: At 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Supportive Care | Number of Patients Who Refused to Participate | 27 Participants |
Primary
Number of Website Visits
Adherence to the intervention will be calculated as the number of website visits. Investigators will calculate and report the mean adherence across all individuals as well as the proportion of patients who completed three or more sessions.
Time frame: At 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Supportive Care | Number of Website Visits | 15.35 website visits | Standard Deviation 12.85 |