Psychosocial telephone counseling for survivors of cervical cancer: results of a randomized biobehavioral trial

Abstract

Purpose: Survivors of cervical cancer experience quality-of-life (QOL) disruptions that persist years after treatment. This study examines the effect of a psychosocial telephone counseling (PTC) intervention on QOL domains and associations with biomarkers.

Patients and methods: We conducted a randomized clinical trial in survivors of cervical cancer, who were ≥ 9 and less than 30 months from diagnosis (n = 204), to compare PTC to usual care (UC). PTC included five weekly sessions and a 1-month booster. Patient-reported outcomes (PROs) and biospecimens were collected at baseline and 4 and 9 months after enrollment. Changes in PROs over time and associations with longitudinal change in cytokines as categorical variables were analyzed using multivariable analysis of variance for repeated measures.

Results: Participant mean age was 43 years; 40% of women were Hispanic, and 51% were non-Hispanic white. Adjusting for age and baseline scores, participants receiving PTC had significantly improved depression and improved gynecologic and cancer-specific concerns at 4 months compared with UC participants (all P < .05); significant differences in gynecologic and cancer-specific concerns (P < .05) were sustained at 9 months. Longitudinal change in overall QOL and anxiety did not reach statistical significance. Participants with decreasing interleukin (IL) -4, IL-5, IL-10, and IL-13 had significantly greater improvement in QOL than those with increasing cytokine levels.

Conclusion: This trial confirms that PTC benefits mood and QOL cancer-specific and gynecologic concerns for a multiethnic underserved population of survivors of cancer. The improvement in PROs with decreases in T-helper type 2 and counter-regulatory cytokines supports a potential biobehavioral pathway relevant to cancer survivorship.

Trial registration: ClinicalTrials.gov NCT00496106.

Fig 1.

CONSORT diagram of ascertainment and recruitment. PTC, psychosocial telephone counseling.

Fig 2.

Longitudinal change in patient-reported outcomes. Data for psychosocial telephone counseling (PTC) patients (solid blue lines) and usual care (UC) patients (dashed gold lines) at baseline, at 4 months (time 2 [T2]), and at 9 months (time 3 [T3]) for individuals for whom data are present for all three time points. Error bars represent SEs. (A) Longitudinal change in the Functional Assessment of Cancer Therapy–Cervical (FACT-Cx) Additional Concerns subscale (n = 145). (B) Longitudinal change in the Gynecologic Problems Checklist (GPC; n = 139). (C) Longitudinal change in the Patient-Reported Outcomes Measurement Information Systems (PROMIS) Depression T-score (n = 149). (D) Longitudinal change in the FACT-Cx for patients whose treatment involved surgery alone (solid blue line represents patients who received PTC, n = 42; dashed gold line represents patients who received UC, n = 37). (E) Longitudinal change in the FACT-Cx for patients whose treatment included radiation therapy (solid blue line represents patients who received PTC, n = 34; dashed gold line represents patients who received UC, n = 36).

Fig 3.

Associations between longitudinal change (time 1 [T1; baseline] to time 2 [T2; 4 months]) in serum cytokine levels and Functional Assessment of Cancer Therapy–Cervical (FACT-Cx) scores. The mean change in FACT-Cx scores is depicted for all patients by quintiles (Qs) of longitudinal change in cytokines; the lowest two Qs represent decreasing changes in cytokines; the middle Q includes zero change; and the highest two Qs represent increasing changes in cytokines (interleukin [IL] -4, n = 103, P = .001; IL-5, n = 114, P = .016; IL-13, n = 102, P = .005) and in the counter-regulatory cytokine IL-10 (n = 114, P = .001).

Fig 4.

Cancer survivorship and a biobehavioral paradigm. (A) A depiction of the biobehavioral paradigm integrating the psychoneuroimmune axis as it pertains to cancer survivorship. The diagnosis and treatment of a tumor imparts chronic psychological and physiologic stress that leads to disruption of multiple domains, which are interconnected via the psychoneuroimmune axis and which lead to decreased psychological and biologic health, resulting in compromised survivorship. (B) The documented impact of the psychosocial telephone counseling (PTC) intervention on this construct. Domain elements were modulated in association with PTC; anxiety (black) did not show significant modulation, and blue text represents elements that were not evaluated. We documented a positive impact of the PTC intervention on three of the four domains supporting a similar positive impact on cancer survivorship. DHEA, dehydroepiandrosterone; IL, interleukin; QOL, quality of life; Th2, T-helper type 2.