Giesler 2005.

Methods	RCT; Unit of allocation: Patient‐spouse dyad; Stratified by: Recruitment site, treatment modality
Participants	Patient with a diagnosis of Stage T1a‐T2c prostate carcinoma and scheduled to undergo or to have undergone surgery, external beam radiation, or brachytherapy. Setting / country: Indiana University Cancer Center, the West Michigan Cancer Center, Ingham Hospital, and the Sparrow Radiation Clinic (Lansing, MI); and the Veterans Administration Medical Center (Louisville, KY) / USA Type of cancer: Prostate Phase of care: Pre‐treatment, surveillance Sample size at randomisation: 99
Interventions	Nurse‐driven cancer care: After the conclusion of treatment for prostate carcinoma, dyads (patient/partner) in the intervention arm met once each month for 6 months with a nurse intervener (twice in person and 4 times by telephone). The nurse intervener identified and tracked quality‐of‐life problems using an assessment program developed for the cancer care intervention that was run from a laptop computer (the proximal‐distal continuum, a framework that is advocated frequently by quality‐of‐life investigators). For each problem, evidence‐based strategies were considered; and a mutually agreed upon, tailored plan of care then was developed and implemented by the nurse and the dyad. During each visit, the menu‐driven computer program provided standardised questions and response formats that the nurse intervener used to elicit and document information concerning quality‐of‐life problems. If a participants score exceeded a pre‐specified threshold for a problem, the program prompted the nurse to assess the problem in greater detail and helped identify strategies for that problem. After the first intervener visit, the program also was used to record whether previously identified problems had resolved or persisted and whether prior strategies should be continued, adjusted in terms of intensity or frequency, or halted. After the first visit, participants were provided with a videotape to view at home which showed couples discussing how cancer had affected their sexuality and relationship, and a binder or tool kit, which contained tabbed pages with information related to managing the symptoms and side effects commonly experienced by patients with prostate carcinoma. Control: Standard care.
Outcomes	Patient: QoL, dyadic adjustment, depression
Notes	Length of follow‐up: 12 months
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "After the baseline interview, participants were randomised to the intervention arm or the control arm, stratified by recruitment site and treatment modality."
Allocation concealment (selection bias)	Unclear risk	See quote first item.
Blinding (performance bias and detection bias) All outcomes	Low risk	Quote: "Interviewers were blind to the group assignment of participants."
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: "By Wave 4, 85 of the original consenting dyads remained in the study, and 14 dyads had dropped out. The primary reason stated for dropping out was inconvenience. Attrition rates across the intervention and standard‐care groups were nearly identical, and drop‐outs did not differ from those who completed the study on any demographic, clinical, or baseline quality‐of‐life variables, with the exception that drop‐outs had marginally worse role‐emotional functioning at baseline (P < 0.07)." Comment: The proportions of missing data in each group were similar, but there is an incomplete reporting of reasons for missing outcomes. For the 2 outcomes that turned out to be significantly changed after the intervention (sexual limitation and cancer worry, Table 2), we replaced missing data with hypothetical results that showed no effect of the intervention. We then observed that the final results were only slightly modified, so we evaluated the risk of bias from missing data to be small.
Selective reporting (reporting bias)	Low risk	All outcomes in the methods section are reported in the results section.
Other bias	Low risk	No evidence of any other bias.
Baseline outcomes similar?	Low risk	Quote: "In regression analyses, interactions between the group variable and other potentially confounding variables also were tested. If an interaction was significant (P < 0.05), then we reported and tested the means (adjusted for age) for the intervention group and the control group separately for each level of the interacting variable. We observed that only baseline depression interacted with group. To describe this interaction, we dichotomised baseline depression into a low group and a high group based on the median (≥ 5 vs. < 5)." Comment: No baseline outcome measures are provided, but the regression analysis performed takes into account differences at baseline. A sensitivity analysis was performed to evaluate the impact of depression on primary outcomes.
Baseline characteristics similar?	Low risk	Quote: "We adjusted for age in all regression models, because intervention and control group participants differed on age (P < 0.001) but not on other characteristics (P < 0.25), including baseline quality‐of‐life variables." Comment: Age was significantly different between groups, but it was adjusted for in all analysis.
Protected against contamination?	Unclear risk	Dyads were the unit of randomisation. There are no details on the control group intervention. We do not know if the nurse involved in the intervention was also involved with control group patients.