Table 2 List of Protocol Changes Undertaken Prior to Participant Enrollment in Response to the COVID-19 Pandemic, per CONSERVE-SPIRIT guidelines

9. Study setting

• Due to the pandemic, we could no longer hold the group sessions in-person onsite in cancer care clinics

• Shift group sessions from in-person to online via video conferencing

• This is a moderately important modification because it changes the physical setting in which participants join the online group sessions, which will now vary from person to person

11. Interventions

• Due to the pandemic, we could no longer hold the group sessions in-person onsite in cancer care clinics

• Shift group sessions from in-person to online via video conferencing

• Add a fifth weekly group session and a booster

• Adapt content delivery for online environment (use of visual slides, breakout rooms)

• These are important modifications because they change the length and delivery of the active study intervention.

13. Participant timeline

• Shift to online group session delivery increased the possibility of participant distraction and the need for extra time to deliver the same material

• Shift study participation one week longer due to addition of 5th weekly group session

• This is a minor modification, as it adds 1 additional week out of 3.5 to 4 total months of study participation.

15. Recruitment

• Could no longer recruit in-person at cancer care clinics

• Did not need to limit recruitment for a given cohort to the clinic hosting the group, as group sessions moved online

• Rely more heavily on mailings and other remote recruitment methods

• Due to group sessions shifting to online delivery, change recruitment for each cohort from site-specific to network-wide

• These are important modifications because they affect both the method and scope of recruitment for each study cohort.

27. Confidentiality

• Moving the groups online made it possible that non-group members (family members, roommates, etc.) could overhear the group

• Request in the first group session that participants join from a private room with a closed door or use headphones, if possible

• This is largely a minor modification reflecting the broader modification of moving the groups online

32. Informed consent materials

• The mitigation strategies listed above changed the study protocol

• Revise the consent form to reflect the changes outlined above

• These are important modifications because they inform participants that the entire active intervention will be delivered remotely as opposed to partially in-person.