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Randomized Controlled Trial
. 2018 Aug;12(4):560-570.
doi: 10.1007/s11764-018-0693-9. Epub 2018 May 5.

An online randomized controlled trial, with or without problem-solving treatment, for long-term cancer survivors after hematopoietic cell transplantation

Karen L Syrjala  1   2 , Jean C Yi  3 , Samantha B Artherholt  3 , Joan M Romano  4 , Marie-Laure Crouch  3 , Allison S Fiscalini  5 , Mark T Hegel  6 , Mary E D Flowers  3   4 , Paul J Martin  3   4 , Wendy M Leisenring  3
Affiliations
Randomized Controlled Trial

An online randomized controlled trial, with or without problem-solving treatment, for long-term cancer survivors after hematopoietic cell transplantation

Karen L Syrjala et al. J Cancer Surviv. 2018 Aug.

Abstract

Purpose: This randomized controlled trial examines the efficacy of INSPIRE, an INternet-based Survivorship Program with Information and REsources, with or without problem-solving treatment (PST) telehealth calls, for survivors after hematopoietic cell transplantation (HCT).

Methods: All adult survivors who met eligibility criteria were approached for consent. Participants completed patient-reported outcomes at baseline and 6 months. Those with baseline impaired scores on one or more of the outcomes were randomized to INSPIRE, INSPIRE + PST, or control with delayed INSPIRE access. Outcomes included Cancer and Treatment Distress, Symptom Checklist-90-R Depression, and Fatigue Symptom Inventory. Planned analyses compared arms for mean change in aggregated impaired outcomes and for proportion of participants improved on each outcome.

Results: Of 1306 eligible HCT recipients, 755 (58%) participated, and 344 (45%) had one or more impaired scores at baseline. We found no reduction in aggregated outcomes for either intervention (P > 0.3). In analyses of individual outcomes, participants randomized to INSPIRE + PST were more likely to improve in distress than controls (45 vs. 20%, RR 2.3, CI 1.0, 5.1); those randomized to INSPIRE alone were marginally more likely to improve in distress (40 vs. 20%, RR 2.0, CI 0.9, 4.5).

Conclusions: The INSPIRE online intervention demonstrated a marginal benefit for distress that improved with the addition of telehealth PST, particularly for those who viewed the website or were age 40 or older.

Implications for cancer survivors: Online and telehealth programs such as INSPIRE offer opportunities to enhance HCT survivorship outcomes, particularly for mood, though methods would benefit from strategies to improve efficacy.

Keywords: Cancer survivor; Hematologic malignancy; Hematopoietic cell transplantation; Internet; Online; Problem solving treatment; Randomized controlled trial; Survivorship; Telehealth.

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Conflict of interest statement

Conflict of Interest Disclosures: none

Figures

Figure 1
Figure 1. Consort diagram for study flow
* Relapse, hospice care, hospitalized so unable to respond
See this image and copyright information in PMC

References

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