Decision Aid for Education and Support About Cancer Treatment

This is a 12-item study-team developed measure used to obtain acceptability ratings from AYA and caregivers (that completed participation in DECIDES or DECIDES+). This measure is based on The Ottawa Hospital's measure of acceptability regarding comprehension of components of a decision aid, its length, pace, amount of information, balance in presentation of information about options, and overall suitability for decision-making. Items are rated on a 5-point Likert scale (1=strongly disagree to 5=strongly agree). The average across 12 items is calculated to produce a total score that ranges from 1-5. Higher scores reflect greater acceptability. Two items related to the DECIDES Coach are not answered by participants in DECIDES who did not have access to a coach.

Time frame: 8 weeks post-randomization

Population: NOTE. Measure was NOT administered to Usual Care group (per protocol).~13 participants were excluded from analyses including:~* n=8 non-protocol adherent participants (5 AYA, 3 Caregivers in the DECIDES group) that did not access the DECIDES intervention~* n=1 Caregiver (in the DECIDES group) with missing data~* n=2 non-protocol adherent participants (1 AYA, 1 Caregiver in the DECIDES+ group) that did not meet with the DECIDES Coach~* n=2 Second Caregivers (in the DECIDES+ group)

This is a 10-item scale collected from AYA and caregivers (that completed participation in DECIDES or DECIDES + coach) and oncology health care providers to measure perceptions of DECIDES usability. Items are rated on a 5-point Likert scale (1=strongly disagree to 5=strongly agree) and summed to produce a total score that ranges from 0 to 100. Scores are normalized to produce a percentile ranking. A score \>80.3 reflects letter grade A (adjective rating excellent); 68-80.3 reflects letter grade B (adjective rating good), 68 reflects letter grade C (adjective rating OK); 51-67 reflects letter grade D (adjective rating poor); and \<51 reflects letter grade F (adjective rating awful).

Time frame: 8 weeks post-randomization

Population: NOTE. Measure was NOT administered to Usual Care group (per protocol). Measure was administered to Oncology Clinicians during Interview.~14 participants were excluded from analyses including:~* n=8 (5 AYA, 3 Caregivers in the DECIDES group) that did not access the DECIDES intervention~* n=2 (1 AYA, 1 Caregiver in the DECIDES+ group) that did not meet with the DECIDES Coach~* n=2 Second Caregivers (in the DECIDES+ group)~* n=2 Oncology Clinicians with missing data

This is a 35-item measure of AYA and caregiver attitudes toward clinical trials. Continuous scores were calculated from PRPQ items reflecting 'Perceived Benefits' (with a higher score suggesting positive attitudes) and from PRPQ items reflecting 'Perceived Barriers' (with a higher score suggesting negative attitudes). A 'Decision Balance' score was computed by converting the 'Perceived Benefits' and 'Perceived Barriers' scores to Z-scores, and then subtracting the 'Perceived Barriers Z-scores' from the 'Perceived Benefits Z-scores'. A 'Decision Balance' Z-score of 0 represents the population mean; a positive valence (3) reflects more positive attitudes to clinical trials and negative valence (-3) reflects more negative attitudes.

Time frame: 8 weeks post-randomization

Population: 12 participants were excluded from analyses including:~* n=8 non-protocol adherent participants (5 AYA, 3 Caregivers in the DECIDES group) that did not access the DECIDES intervention~* n=2 non-protocol adherent participants (1 AYA, 1 Caregiver in the DECIDES+ group) that did not meet with the DECIDES Coach~* n=2 Second Caregivers (in the DECIDES+ group)

This is a 25-item true/false questionnaire used to assess participant understanding of clinical trials and informed consent processes. Items are scored based on % correct, with higher scores reflecting more knowledge.

Time frame: 8-weeks post randomization

Population: 12 participants were excluded from analyses including:~* n=8 non-protocol adherent participants (5 AYA, 3 Caregivers in the DECIDES group) that did not access the DECIDES intervention~* n=2 non-protocol adherent participants (1 AYA, 1 Caregiver in the DECIDES+ group) that did not meet with the DECIDES Coach~* n=2 Second Caregivers (in the DECIDES+ group)

The SDM-Q-9 is a valid and reliable 9-item patient-reported questionnaire collected from AYA to measure their perceived involvement in the process of shared treatment decision-making with their oncology clinician. The physician version of the SDM-Q-9 (SDM-Q-Doc) was adapted for use with caregivers in this study to measure AYA involvement in shared decision-making with their oncology clinician, from the caregiver's perspective. Total scores range from 0 to 100. Higher scores reflect greater degree to which AYA were involved in a shared treatment decision-making process.

Time frame: 8 weeks post-randomization

Population: 12 participants were excluded from analyses including:~* n=8 non-protocol adherent participants (5 AYA, 3 Caregivers in the DECIDES group) that did not access the DECIDES intervention~* n=2 non-protocol adherent participants (1 AYA, 1 Caregiver in the DECIDES+ group) that did not meet with the DECIDES Coach~* n=2 Second Caregivers (in the DECIDES+ group)

This is a 5-item scale that measures AYA and caregiver perceptions of the extent to which clinicians engaged in five key elements of the decision-making process (e.g., discuss the available options with you in a way you could understand?, encourage you to ask questions or express any concerns you had about the available options?, involve you as much as you wanted in the decision making process?). The overall physician style score ranges from 0-100. Higher scores reflect more optimal communication with physician.

Time frame: 8 weeks post-randomization

Population: 12 participants were excluded from analyses including:~* n=8 non-protocol adherent participants (5 AYA, 3 Caregivers in the DECIDES group) that did not access the DECIDES intervention~* n=2 non-protocol adherent participants (1 AYA, 1 Caregiver in the DECIDES+ group) that did not meet with the DECIDES Coach~* n=2 Second Caregivers (in the DECIDES+ group)

This is a valid and reliable 5-item scale collected from AYA and caregivers to measure distress or remorse about a cancer treatment decision. Total scores range from 0 (no regret) to 100 (high regret).

Time frame: 8 weeks post-randomization

Population: 12 participants were excluded from analyses including:~* n=8 non-protocol adherent participants (5 AYA, 3 Caregivers in the DECIDES group) that did not access the DECIDES intervention~* n=2 non-protocol adherent participants (1 AYA, 1 Caregiver in the DECIDES+ group) that did not meet with the DECIDES Coach~* n=2 Second Caregivers (in the DECIDES+ group)

This is a valid and reliable 6-item scale collected from AYA and caregivers to measure satisfaction with the cancer treatment decision that was made. Total scores range from 6 to 30, with higher scores reflecting higher satisfaction.

Time frame: 8 weeks post-randomization

Population: 12 participants were excluded from analyses including:~* n=8 non-protocol adherent participants (5 AYA, 3 Caregivers in the DECIDES group) that did not access the DECIDES intervention~* n=2 non-protocol adherent participants (1 AYA, 1 Caregiver in the DECIDES+ group) that did not meet with the DECIDES Coach~* n=2 Second Caregivers (in the DECIDES+ group)

This is a valid and reliable 11-item scale collected from AYA and caregivers to measure self-confidence in decision-making abilities. Total scores range from 0 (not confident) to 100 (extremely confident).

Time frame: 8 weeks post-randomization

Population: 12 participants were excluded from analyses including:~* n=8 non-protocol adherent participants (5 AYA, 3 Caregivers in the DECIDES group) that did not access the DECIDES intervention~* n=2 non-protocol adherent participants (1 AYA, 1 Caregiver in the DECIDES+ group) that did not meet with the DECIDES Coach~* n=2 Second Caregivers (in the DECIDES+ group)

This is a valid and reliable 16-item scale collected from AYA and caregivers to measure uncertainty in making cancer treatment decisions, including factors that contribute to uncertainty about cancer treatment options and perceptions of effective decision-making. Total scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict).

Time frame: 8 weeks post-randomization

Population: 12 participants were excluded from analyses including:~* n=8 non-protocol adherent participants (5 AYA, 3 Caregivers in the DECIDES group) that did not access the DECIDES intervention~* n=2 non-protocol adherent participants (1 AYA, 1 Caregiver in the DECIDES+ group) that did not meet with the DECIDES Coach~* n=2 Second Caregivers (in the DECIDES+ group)